SAN FRANCISCO and TOKYO, Sept. 20, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN, Interim CEO: James A. Schoeneck, FibroGen) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas) today announced that Japans Ministry of Health, Labour and Welfare (MHLW) approved Evrenzo (generic name: roxadustat; tradename Evrenzo in Japan) for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients.
Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolylhydroxylase that corrects anemia by a mechanism of action that is different from that of erythropoiesis-stimulating agents (ESAs). As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. The response activated by roxadustat involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the bloods oxygen-carrying capacity.
"Evrenzo is a valuable new treatment option for dialysis patients with CKD anemia, said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. 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. We are delighted to bring this important new treatment option to both patients suffering from, and healthcare professionals treating, this debilitating condition.
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.
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. With this approval in Japan, NDA approval in China, and EU MAA and U.S. NDA preparations underway, we are another step closer to our goal of addressing the significant unmet medical need of patients living with anemia associated with CKD, worldwide.
The approval is based on four Phase 3 studies conducted in CKD anemia patients on dialysis in Japan.4,5,6,7The studies demonstrated that roxadustat was effective at raising hemoglobin and that it was well-tolerated. This marks the first approval for roxadustat through the Astellas and FibroGen collaboration.
Product Information
Patients switching from erythropoiesis-stimulating agents. For adults, the usual dosage is 70 or 100mg, the starting dose, as roxadustat orally administered three times weekly. The dosage thereafter should be adjusted according to the patients condition; however, the maximum dose should not exceed 3.0mg/kg.
About Chronic Kidney Disease (CKD) and AnemiaCKD 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. CKD is a critical worldwide healthcare issue that represents a large and growing unmet medical need.
Anemia is a common early complication of CKD,11 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.14,15In 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.
About Roxadustat In addition to receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, roxadustat is approved in China for treatment of anemia associated with CKD in both dialysis-dependent and non-dialysis-dependent CKD patients. U.S. NDA and EU MAA preparation is underway. Roxadustatis alsoinPhase 3 clinical development in the U.S. and Europe andinPhase 2/3 development in China for anemia associated withmyelodysplasticsyndromes.For information about roxadustat studies, please visit http://www.clinicaltrials.gov at: https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search.
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. 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.
About FibroGen FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, Peoples Republic of China, 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) and connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the companys most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (HIF-PH) activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), and is approved by the National Medical Products Administration (NMPA) in China, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Roxadustat is 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 (MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit http://www.fibrogen.com.
About AstellasAstellas 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. For more information, please visit https://www.astellas.com/en.
FibroGen Forward-looking Statements This release contains forward-looking statements regarding FibroGen strategy, future plans and prospects, including statements regarding the development of the companys product candidates, the potential safety and efficacy profile of our product candidates, and our clinical and regulatory plans, and those of our partners. 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. 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. 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.
Astellas Cautionary NotesIn 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. These statements are based on managements current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. 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.
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.
Contacts for inquiries or additional information:
Karen L. Bergman FibroGen, Inc.Investor Relations and Corporate Communications+1 (415) 978-1433ir@fibrogen.com
Astellas Pharma Inc.Corporate CommunicationsTEL: +81-3-3244-3201 FAX: +81-3-5201-7473
References:
1 Mohanram A, Zhang Z, Shahinfar S,ET AL. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. Kidney Int. 2004 Sep;66(3):1131-8.
2 Weiner DE , Tighiouart H, Stark PC et al. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. Am J Kidney Dis. 2004 Aug;44(2):198-206.
3 Eriksson D et al. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrology. 2016;17:97.
4 1517-CL-0302: Announced on a press release issued on October 31, 2017. 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. 29 of presentation material at Astellas FY2017 business announcement on April 26, 2018. 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. 29 of presentation material at Astellas FY2017 business announcement on April 26, 2018. 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. Available at: https://www.astellas.com/jp/en/news/11951
8 Ojo, A. Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translational Research. Transactions of the American Clinical and Climatological Association. 2014, No. 125, p. 229-246.
9 The Global Kidney Health Atlas. International Society of Nephrology (ISN). Available at: https://www.kidneycareuk.org/news-and-campaigns/news/estimated-1-10-people-worldwide-have-chronic-kidney-disease/. Last accessed August 2019.
10 Nagata M, Ninomiya T, Doi Y, Yonemoto K, Kubo M, Hata J, Tsuruya K, Iida M, Kiyohara Y. Nephrol Dial Transplant. 2010, Aug, vol. 25, no.8, 2557-2564.
11 McClellan W, Aronoff SL, Bolton WK, et al. The prevalence of anemia in patients with chronic kidney disease.Curr.Med.Res.Opin.2004;20:15011510.
12 Dmitrieva O, De Lusignan S, Macdougall, IC, et al. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. BMC Nephrology. 2013:25;14:24.
13 KDOQINational Kidney Foundation: KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 47 [Suppl 3]: S11S145, 2006.
14 Eriksson D et al. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrology. 2016;17:97.
15 KDOQINational Kidney Foundation: KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 47 [Suppl 3]: S11S145, 2006.
- Muscular .Dystrophy -Successful-treatment by acupressure , Ayurveda, Yoga - May 10th, 2011 [May 10th, 2011]
- Muscular Dystrophy Treatment - Todd Harrison Improving Balance - May 16th, 2011 [May 16th, 2011]
- Oculopharyngeal Muscular Dystrophy (OPMD): Exploring Causes and Treatment - May 20th, 2011 [May 20th, 2011]
- Muscular Dystrophy Treatment - Todd Harrison holding body weight - May 21st, 2011 [May 21st, 2011]
- David G VECTTOR Muscular Dystrophy Treatment double arm strength month 6 - May 22nd, 2011 [May 22nd, 2011]
- David Gould Becker Muscular Dystrophy VECTTOR Treatment - June 2nd, 2011 [June 2nd, 2011]
- Muscular Dystrophy Halo - June 3rd, 2011 [June 3rd, 2011]
- Muscular Dystrophy VECTTOR Treatment Documentary - Todd's 6 Month Journey - June 7th, 2011 [June 7th, 2011]
- Muscular Dystrophy Treatment Results - David Gould - New Footage - June 8th, 2011 [June 8th, 2011]
- Muscular Dystrophy - Rewriting History with VECTTOR - June 10th, 2011 [June 10th, 2011]
- Muscular Dystrophy - David Gould 5 month VECTTOR treatment for BMD - June 12th, 2011 [June 12th, 2011]
- Duchenne's Muscular Dystrophy Stem Cell Treatment - Reelabs India - June 14th, 2011 [June 14th, 2011]
- Muscular Dystrophy VECTTOR Treatment - Todd Harrison/Luau Presentation - June 16th, 2011 [June 16th, 2011]
- Dr. William Rader - Muscular Dystrophy Breakthrough - June 16th, 2011 [June 16th, 2011]
- Muscular Dystrophy patient at Xcell-center - Nabeel Mohamed Abdulhusain, 46 years - June 17th, 2011 [June 17th, 2011]
- Charlie's Story: Duchenne Muscular Dystrophy Part 4 - July 18th, 2011 [July 18th, 2011]
- Muscular Dystrophy VECTTOR Treatment - David Gould/Luau Presentation - July 19th, 2011 [July 19th, 2011]
- Testimonial 4 of Muscular Dystrophy after Stem Cell Therapy - August 5th, 2011 [August 5th, 2011]
- Drug Combo Dynamic in Muscular Dystrophy - August 9th, 2011 [August 9th, 2011]
- Testimonial for Fetal Stem Cell Treatment of Duchenne Muscular Dystrophy - August 25th, 2011 [August 25th, 2011]
- Improvement seen in Duchenne Muscular Dystrophy after Stem Cell Therapy - September 11th, 2011 [September 11th, 2011]
- Muscular Dystrophy STS/VECTTOR treatment results - September 24th, 2011 [September 24th, 2011]
- Muscular Dystrophy VECTTOR Treatment Documentary - Todd's One Year Journey - October 2nd, 2011 [October 2nd, 2011]
- Muscular Dystrophy Treatment Day 18 - Todd Harrison's Improvement - October 2nd, 2011 [October 2nd, 2011]
- Wang Yisheng - Muscular Dystrophy Adult Stem Cell Patient - October 9th, 2011 [October 9th, 2011]
- Becker Muscular Dystrophy Miracle TREATMENT - October 11th, 2011 [October 11th, 2011]
- Muscular dystrophy patient_Kleber_Brazil.wmv - October 12th, 2011 [October 12th, 2011]
- Testimonial 1 of Muscular Dystrophy after Stem Cell Therapy - Video - October 18th, 2011 [October 18th, 2011]
- Becker Muscular Dystrophy STS Treatment - Video - October 18th, 2011 [October 18th, 2011]
- Potential Stem Cell treatment of Duchenne Muscular Dystrophy - Video - October 21st, 2011 [October 21st, 2011]
- Muscular Dystrophy treated by Dr Rajesh Shah at Life Force - Video - October 22nd, 2011 [October 22nd, 2011]
- Defying Muscular Dystrophy - I Made It - Video - October 23rd, 2011 [October 23rd, 2011]
- Becker Muscular Dystrophy AMAZING treatment results - Video - October 27th, 2011 [October 27th, 2011]
- First targeted treatment success for Duchenne muscular dystrophy - Video - November 6th, 2011 [November 6th, 2011]
- 125 Days of VECTTOR Treatment Progress - November 18th, 2011 [November 18th, 2011]
- Becker Muscular Dystrophy WALKING ABILITY IMPROVED - Video - November 25th, 2011 [November 25th, 2011]
- PT Muscular Dystrophy Treatment Results - Video - December 5th, 2011 [December 5th, 2011]
- Duchenne Muscular Dystrophy Treated by Cellmedicine - Video - January 8th, 2012 [January 8th, 2012]
- muscular DYSTROPHY treatment IN HOMEOPATH.mp4 - Video - January 28th, 2012 [January 28th, 2012]
- Giulio's strategy is to cure dystrophy with stem cell treatment - Video - January 31st, 2012 [January 31st, 2012]
- Parent Project Muscular Dystrophy is a Featured Nonprofit Selected by Webkinz(TM) Foundation - February 1st, 2012 [February 1st, 2012]
- MDA Awards More Than $12 Million in Grants to Advance Neuromuscular Disease Research - February 1st, 2012 [February 1st, 2012]
- "For treatment we will have in the future" - Video - February 2nd, 2012 [February 2nd, 2012]
- Renowned Pediatric Cardiology Physician-Scientist Linda Cripe Joins Nationwide Children's Hospital - February 3rd, 2012 [February 3rd, 2012]
- JumpStart Invests $250,000 in Milo Biotechnology - February 14th, 2012 [February 14th, 2012]
- When nerve meets muscle, biglycan seals the deal - February 14th, 2012 [February 14th, 2012]
- Medical clinics offer help for Big Island children - February 16th, 2012 [February 16th, 2012]
- Dateline Long Beach: The Aquatic Center brings swim therapy to disabled - February 19th, 2012 [February 19th, 2012]
- Parent Project Muscular Dystrophy Awards $500,000 to Tivorsan Pharmaceuticals - February 21st, 2012 [February 21st, 2012]
- Cure Duchenne Announces Three New Funded Research Projects to Help Develop Treatments and Find a Cure for Duchenne ... - February 21st, 2012 [February 21st, 2012]
- Ligand Licenses DARA Program to Retrophin - February 21st, 2012 [February 21st, 2012]
- AVI BioPharma Regains NASDAQ Compliance - February 23rd, 2012 [February 23rd, 2012]
- Scientists create potent molecules aimed at treating muscular dystrophy - February 23rd, 2012 [February 23rd, 2012]
- AVI BioPharma Announces Fourth Quarter and Full Year 2011 Financial Results and Corporate Update Conference Call - February 23rd, 2012 [February 23rd, 2012]
- Pembroke's Christine McSherry is an 'Inspirational Woman' - February 25th, 2012 [February 25th, 2012]
- The Rare Clinical Diseases Research Network - February 25th, 2012 [February 25th, 2012]
- A Solution for Duchenne Muscular Dystrophy? - Research Summary - February 28th, 2012 [February 28th, 2012]
- A Solution for Duchenne Muscular Dystrophy? -- In Depth Doctor's Interview - February 28th, 2012 [February 28th, 2012]
- Antisense oligonucleotides make sense in myotonic dystrophy - February 28th, 2012 [February 28th, 2012]
- A life of dependence - February 29th, 2012 [February 29th, 2012]
- Nationwide Children's Hospital neuromuscular disorder podcasts now available on iTunes - March 2nd, 2012 [March 2nd, 2012]
- Next-generation DNA sequencing to improve diagnosis for muscular dystrophy - March 6th, 2012 [March 6th, 2012]
- The Dire Limits of Health Care - March 7th, 2012 [March 7th, 2012]
- AVI BioPharma Announces Late-Breaker Oral Presentation of Phase IIb DMD Study at 2012 AAN Annual Meeting in April - March 12th, 2012 [March 12th, 2012]
- Cataracts affect millions of people around the globe, and for many of us they will be a normal part of our aging ... - March 14th, 2012 [March 14th, 2012]
- Your Health: Duchenne's Muscular Dystrophy - March 16th, 2012 [March 16th, 2012]
- Newborn Screening for Duchenne Muscular Dystrophy Shows Promise as an International Model - March 20th, 2012 [March 20th, 2012]
- Newborn screening for DMD shows promise as an international model - March 20th, 2012 [March 20th, 2012]
- Rhenovia launches drug discovery for Huntington's disease - March 20th, 2012 [March 20th, 2012]
- Halo Therapeutics Reports Favorable Independent Review of Lead Drug Candidate HT-100 - March 21st, 2012 [March 21st, 2012]
- Invasive treatment strategy may increase survival for patients with certain neuromuscular disorder - March 28th, 2012 [March 28th, 2012]
- Parent Project Muscular Dystrophy Endorses FAST Act Legislation to Expedite FDA Review of Life-Saving Therapies - March 29th, 2012 [March 29th, 2012]
- AVI BioPharma Announces Conference Call and Webcast on Monday, April 2, 2012, to Discuss Top-Line Data Results From ... - March 31st, 2012 [March 31st, 2012]
- Drug for rare disease may lift AVI BioPharma shares: Barron's - April 2nd, 2012 [April 2nd, 2012]
- AVI BioPharma Announces Eteplirsen Meets Primary Endpoint, Demonstrating a Significant Increase in Dystrophin at 24 ... - April 2nd, 2012 [April 2nd, 2012]
- U.S. Stock Futures Little Changed Before Factory Report - April 2nd, 2012 [April 2nd, 2012]
- Leading experts on congenital muscular dystrophy convene at University of Nevada, Reno - April 20th, 2012 [April 20th, 2012]
- Nature Publishes Work Utilizing N-Gene's Core Technology to Advance the Treatment of Duchenne Muscular Dystrophy - April 20th, 2012 [April 20th, 2012]
- Getting the boots filled - April 29th, 2012 [April 29th, 2012]
- Local business, civic leaders 'arrested' for MDA fundraiser - May 3rd, 2012 [May 3rd, 2012]