4 1517-CL-0302: Announced on a press release issued on October 31, 2017. Am J Kidney Dis 47 [Suppl 3]: S11–S145, 2006. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. California Declaration of Comprehensive Compliance Program, Vermontâs Pharmaceutical Marketer Price Disclosure, Wholesale Acquisition Cost Information for Colorado Prescribers, Consumer Product Safety Commission Regulations, https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search, https://www.astellas.com/jp/en/news?type=date&tab=date&year=2017&month=10, https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf, https://www.astellas.com/jp/en/news/11951, https://www.kidneycareuk.org/news-and-campaigns/news/estimated-1-10-people-worldwide-have-chronic-kidney-disease/. 2004 Aug;44(2):198-206. Am J Kidney Dis 47 [Suppl 3]: S11–S145, 2006. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage Information Pediatric patients (1 year to less than 17 years) This release contains forward-looking statements regarding FibroGen strategy, future plans and prospects, including statements regarding the development of the company's product candidates, the potential safety and efficacy profile of our product candidates, and our clinical and regulatory plans, and those of our partners. 29 of presentation material at Astellas FY2017 business announcement on April 26, 2018. 25, no.8, 2557-2564. 2 Weiner DE, Tighiouart H, Stark PC et al. TOKYO and SAN FRANCISCO, Sept. 20, 2019 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, Interim CEO: James A Schoeneck., "FibroGen") today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved Evrenzo® (generic name: roxadustat) for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients. FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that corrects anemia by a mechanism of action that is different from that of erythropoiesis-stimulating agents (ESAs). 15 KDOQINational Kidney Foundation: KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. CKD is a critical worldwide healthcare issue that represents a large and growing unmet medical need. Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases that Erelzi is used for. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Please read our privacy policy for more information on the cookies we use, the processing of your personal data and how to delete or block the use of cookies. 9 The Global Kidney Health Atlas. For more information about using Erelzi, see the package leaflet or contact your doctor or pharmacist. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and our quarterly report on 10-Q for the fiscal quarter ended June 30, 2019 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. full prescribing information: contents* 1 indications and usage 2 dosage and administration 3 dosage forms and strengths 4 contraindications 5 warnings and precautions 5.1 flammability 6 adverse reactions 6.1 clinical trials experience 7 drug interactions 7.1 warfarin 8 use in specific populations Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. Am J Kidney Dis 47 [Suppl 3]: S11âS145, 2006. Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. These highlights do not include all the information needed to use OZEMPIC® safely and effectively. Follow all instructions closely. See full prescribing information for administration instructions (2.4) -----DOSAGE FORMS AND STRENGTHS----- Injection: 100 mg/0.67 mL solution in a single-use prefilled syringe for subcutaneous injection. 10 Nagata M, Ninomiya T, Doi Y, Yonemoto K, Kubo M, Hata J, Tsuruya K, Iida M, Kiyohara Y. Nephrol Dial Transplant. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. U.S. NDA and EU MAA preparation is underway. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, and other markets. Am J Kidney Dis. 2016;17:97. "Evrenzo® is a valuable new treatment option for dialysis patients with CKD anemia," said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. The response activated by roxadustat involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the blood's oxygen-carrying capacity. CKD is a critical worldwide healthcare issue that represents a large and growing unmet medical need. 2004 Aug;44(2):198-206. The prevalence of anemia in patients with chronic kidney disease. Curr.Med.Res.Opin. 2004;20:1501â1510. Last accessed August 2019. FULL PRESCRIBING INFORMATION. You are now leaving www.astellas.com/us. Transactions of the American Clinical and Climatological Association. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. International Society of Nephrology (ISN). The dosage thereafter should be adjusted according to the patient's condition; however, the maximum dose should not exceed 3.0mg/kg. Available at: https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf, 7 1517-CL-0307: Announced on a press release issued on May 31. This website is intended for U.S. residents only. Roxadustat is also in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes. BMC Nephrology. 2014, No. BMC Nephrology. DEMADEX is indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease. "We appreciate the commitment and focus of our partner Astellas as we work together to bring a new therapy to CKD anemia patients on dialysis in Japan," said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. How and where to buy Evrenzo: You can order Evrenzo from TheSocialMedwork if the drug has not been approved or is not available in your country. CKD anemia can severely worsen the outcomes of kidney disease, increasing the rate of progression to renal failure1 and the likelihood of cardiovascular complications.2 It also significantly reduces patients' quality of life and their cognitive ability.3 Reaching and maintaining target hemoglobin levels can present challenges and roxadustat provides an alternative therapeutic option. "With this approval in Japan, NDA approval in China, and EU MAA and US NDA preparations underway, we are another step closer to our goal of addressing the significant unmet medical need of patients living with anemia of CKD, worldwide.". When typing in this field, a list of search results will appear and be automatically updated as you type. This document aims to support the appropriate prescribing of benzodiazepines and z-drugs (BZRA) in Ireland. Evrenzo Tablets_Astellas Pharma_review report The usual adult dosage is 50 mg of roxadustat administered orally 3 times weekly. Patients switching from erythropoiesis-stimulating agents. How does Evrenzo (roxadustat) work? Steady results as projected for the first year of Strategic Plan 2018. Take with a full glass of water. Available at: https://www.kidneycareuk.org/news-and-campaigns/news/estimated-1-10-people-worldwide-have-chronic-kidney-disease/. Transactions of the American Clinical and Climatological Association. This release contains forward-looking statements regarding FibroGen strategy, future plans and prospects, including statements regarding the development of the company's product candidates, the potential safety and efficacy profile of our product candidates, and our clinical and regulatory plans, and those of our partners. See full prescribing information for VERZENIO. The website you are linking to is neither owned nor controlled by Astellas. 11 McClellan W, Aronoff SL, Bolton WK, et al. Swallow whole. HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search, https://www.astellas.com/jp/en/news?type=date&tab=date&year=2017&month=10, https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf, https://www.astellas.com/jp/en/news/11951, https://www.kidneycareuk.org/news-and-campaigns/news/estimated-1-10-people-worldwide-have-chronic-kidney-disease/. About Chronic Kidney Disease (CKD) and Anemia. Moderate to Severe Rheumatoid Arthritis (RA) ERELZI is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderately to severely active rheumatoid arthritis. 1 Mohanram A, Zhang Z, Shahinfar S,ET AL. This marks the first approval for roxadustat through the Astellas and FibroGen collaboration. Available at: https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf, 6 1517-CL-0312: Announced on slide no. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Complicated Intra-abdominal Infections XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, See full prescribing information for OZEMPIC®. 1 INDICATIONS AND USAGE 1.1 Edema . By using this site, you accept our use of cookies as described in our privacy policy. See full prescribing information for VIIBRYD. Graduated syringe allows for doses between 20 mg and 100 mg. (3) Anemia is a common early complication of CKD11, affecting approximately 20% of patients with CKD.12 It results from the failing kidneys' diminished ability to produce erythropoietin that stimulates red blood cell production from the bone marrow, and is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.13 CKD anemia increases the risk of adverse cardiovascular events, worsens renal outcomes and negatively impacts patients' quality of life.14,15 In addition, CKD can be both a cause and a consequence of cardiovascular disease and is now a critical worldwide healthcare issue that represents a large and growing unmet medical need. 5 to <7.5 kg: … Take on an empty stomach. BMC Nephrology. Patients not on erythropoiesis-stimulating agent treatment. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. "We appreciate the commitment and focus of our partner Astellas as we work together to bring a new therapy to CKD anemia patients on dialysis in Japan," said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that corrects anemia by a mechanism of action that is different from that of erythropoiesis-stimulating agents (ESAs). The response activated by roxadustat involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the blood's oxygen-carrying capacity. Available at: https://www.astellas.com/jp/en/news/11951, 8 Ojo, A. This will be sent as part of the prescription inform… 12 Dmitrieva O, De Lusignan S, Macdougall, IC, et al. Patients switching from erythropoiesis-stimulating agents. 125, p. 229-246. The starting dosage for patients switching from another renal anemia drug (erythropoiesis-stimulating agent): The usual adult dosage is 70 mg or 100 mg of roxadustat administered orally 3 times weekly. 10 Nagata M, Ninomiya T, Doi Y, Yonemoto K, Kubo M, Hata J, Tsuruya K, Iida M, Kiyohara Y. Nephrol Dial Transplant. "Evrenzo ® is a valuable new treatment option for dialysis patients with CKD anemia," said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. 25, no.8, 2557-2564. For further information: Astellas Pharma Inc., Corporate Communications, TEL: +81-3-3244-3201 FAX: +81-3-5201-7473; FibroGen, Inc., Investor Relations and Corporate Communications, +1 (415) 978-1433, [email protected]. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. 14 Eriksson D et al. For more information, please visit https://www.astellas.com/en. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. Available at: https://www.astellas.com/jp/en/news/11951. 12 Dmitrieva O, De Lusignan S, Macdougall, IC, et al. Roxadustat is also in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes. For information about roxadustat studies, please visit clinicaltrials.gov at: https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search. For some, gearing up for e-prescribing will mean updating already existing systems to enable controlled substance prescriptions. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law. Indicated in combination with other antiretroviral agents for HIV-1 infection in pediatric patients >3 months old and weighing ≥3.5 kg. 9 The Global Kidney Health Atlas. Curr.Med.Res.Opin. 29 of presentation material at Astellas FY2017 business announcement on April 26, 2018. The medicine can only be obtained with a prescription. BMC Nephrology. Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. "Astellas is committed to improving the health of people worldwide and expanding treatment options, especially within the dialysis community where there is high-unmet need. Kidney Int. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. For adults, the usual dosage is 70 or 100mg, the starting dose, as roxadustat orally administered three times weekly. <3 months: Safety and efficacy not established. Both of the latest approvals cover patients regardless of their dialysis status, and they follow a green light for Evrenzo (roxadustat) in the more severe dialysis population in September 2019. Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translational Research. The approval is based on four Phase 3 studies conducted in CKD anemia patients on dialysis in Japan.4,5,6,7 The studies demonstrated that roxadustat was effective at raising hemoglobin and that it was well-tolerated. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. 2014, No. Cision Distribution 888-776-0942 In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. 2004 Sep;66(3):1131-8. Kidney Int. For adults, the usual dosage is 70 or 100mg, the starting dose, as roxadustat orally administered three times weekly. "With this approval in Japan, NDA approval in China, and EU MAA and US NDA preparations underway, we are another step closer to our goal of addressing the significant unmet medical need of patients living with anemia of CKD, worldwide.". The prevalence of anemia in patients with chronic kidney disease. Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Available at: https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf, 6 1517-CL-0312: Announced on slide no. Efavirenz capsules in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. Am J Kidney Dis 47 [Suppl 3]: S11âS145, 2006. 125, p. 229-246.Â. OZEMPIC® (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017 WARNING: RISK OF THYROID C−CELL TUMORS See full prescribing information for complete boxed warning. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Available at: https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf, 7 1517-CL-0307: Announced on a press release issued on May 31. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Indication & Important Safety Information Indication Verzenio is indicated for the treatment of hormone receptor–positive (HR+), human epidermal growth factor receptor 2−negative (HER2–) advanced or metastatic breast cancer (MBC) 1 : HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VERZENIO safely and effectively. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and our quarterly report on 10-Q for the fiscal quarter ended June 30, 2019 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. The approval is based on four Phase 3 studies conducted in CKD anemia patients on dialysis in Japan.4,5,6,7 The studies demonstrated that roxadustat was effective at raising hemoglobin and that it was well-tolerated. 8 Ojo, A. Astellas and FibroGen are collaborating on the development of roxadustat for the potential treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. CKD anemia can severely worsen the outcomes of kidney disease, increasing the rate of progression to renal failure1 and the likelihood of cardiovascular complications.2 It also significantly reduces patients' quality of life and their cognitive ability.3 Reaching and maintaining target hemoglobin levels can present challenges and roxadustat provides an alternative therapeutic option. For more information, please visit https://www.astellas.com/en. For more information, please visit www.fibrogen.com. The dosage thereafter should be adjusted according to the patient's condition; however, the maximum dose should not exceed 3.0mg/kg. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. 2016;17:97. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. The response activated by roxadustat involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the blood's oxygen-carrying capacity. U.S. NDA and EU MAA preparation is underway. 15 KDOQINational Kidney Foundation: KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EVISTA safely and effectively. The prescriber can note the reason for prescribing and make other comments at the time of prescribing. The dosage thereafter should be adjusted according to the patient's condition; however, the maximum dose should not exceed 3.0mg/kg. Last accessed August 2019. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. 2004 Sep;66(3):1131-8. Patients not on erythropoiesis-stimulating agent treatment. Automated solutions, however, can seamlessly send information to a designated health information exchange (HIE) or directly to another provider’s EHR. INDICATIONS. It contains information on initiation and review of BZRA, highlighting the potential dangers associated with long-term use and provides examples of resource materials which may support 2016;17:97. Evrenzo: roxadustat: September 2019: Eylea: aflibercept (genetical recombination) June 2015 See full prescribing information for EVISTA. Electronic prescribing and administration (ePA) systems enable prescribing, dispensing and administration of medicines to be recorded electronically. Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translational Research. BMC Nephrology. EVISTA (raloxifene hydrochloride)Tabletfor Oral Use Initial U.S. Approval: 1997 WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. CKD is a progressive loss of kidney function caused by damage to the kidneys resulting from conditions such as hypertension, diabetes, or immune-regulated inflammatory conditions.8 Worldwide, more than 1 in 10 people are living with CKD.9 In Japan, specifically, the prevalence of CKD has increased significantly over time.10 Although CKD can occur at any age, it becomes more common in aging populations, and the prevalence is increasing. Feature Stories showcase the people and programs that bring to life the Astellas Way values and culture. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. from 8 AM - 9 PM ET. VERZENIO™ (abemaciclib) tablets, for oral use Initial U.S. Approval: 2017----- … 3 Eriksson D et al. 1.2 . Available at: https://www.astellas.com/jp/en/news?type=date&tab=date&year=2017&month=10, 5 1517-CL-0308: Announced on slide no. We are delighted to bring this important new treatment option to both patients suffering from, and healthcare professionals treating, this debilitating condition.". Available at: https://www.astellas.com/jp/en/news?type=date&tab=date&year=2017&month=10, 5 1517-CL-0308: Announced on slide no. 2013:25;14:24. This website contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, or in different dosages.
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