In a recent interview with PharmaShots, Peony Yu, Chief Medical Officer of FibroGen shared her insights and highlights on data of Roxadustat
- FibroGen presented new efficacy and safety analyses from the roxadustat global P-III program at ASN Kidney Week 2020 Reimagined. FibroGen and its partners, AstraZeneca and Astellas, presented 42 abstracts, including 2 late-breaker poster presentations, and 10 oral presentations
- The roxadustat clinical data demonstrated consistent efficacy and reassuring safety results across the continuum of CKD patients with anemia
- FibroGen is pursuing groundbreaking research and science to drive forward a pipeline that may transform the patient experience and create new standards of care in anemia and an array of serious fibrotic conditions
Tuba: Can you briefly summarize the presentation & abstracts of P-III Global Program of roxadustat at ASN Kidney Week 2020 Reimagined?
Peony Yu: FibroGen presented new efficacy and safety analyses from the roxadustat global Phase 3 program at American Society of Nephrology (ASN) Kidney Week 2020 Reimagined. FibroGen and its partners, AstraZeneca and Astellas, presented 42 abstracts, including 2 late-breaker poster presentations, and 10 oral presentations.
- Twenty-eight presentations on roxadustat for the treatment of anemia associated with CKD further demonstrated the depth and breadth of the roxadustat global Phase 3 development program and build on the known clinical profile of roxadustat in treating a broad spectrum of CKD patients.
- Twelve presentations on CKD anemia epidemiology and disease state outlined the burden of anemia on CKD patients and their unmet medical need for innovative therapies.
- Two late-breaking poster presentations explored associations between cardiovascular safety and hemoglobin levels achieved with roxadustat in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD patients.
Tuba: What are the knock-on effects of the newly released roxadustat data?
Peony Yu: The roxadustat clinical data at ASN Kidney Week 2020 Reimagined demonstrated consistent efficacy and reassuring safety results across the continuum of chronic kidney disease patients with anemia, adding to the established body of evidence highlighting roxadustat as a potential foundational treatment for this condition affecting millions of patients.
Roxadustat, being the first oral medicine for the treatment of CKD anemia which can be administered in patients’ homes, is conducive for telehealth as patients no longer need to receive treatment via injections in doctors’ offices or hospital infusion centers.
Tuba: Can you quickly recall your collaboration with AstraZeneca & Astellas for roxadustat?
Peony Yu: AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand, as well as Southeast Asia.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.
Tuba: Can you highlight the expansion of the clinical development of roxadustat in CKD & other indications?
Peony Yu: The roxadustat NDA for the treatment of anemia in CKD in patients on dialysis and those not on dialysis is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. Roxadustat is also in Phase 3 clinical development for anemia associated with myelodysplastic syndromes (MDS) and Phase 2 clinical development for chemotherapy-induced anemia (CIA).
Roxadustat is approved in China for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis. In Japan, roxadustat is approved for the treatment of anemia in CKD patients on dialysis, and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review.
The marketing authorization application (MAA) of roxadustat for treatment of CKD in Europe is under review by the EMA. Similarly, the roxadustat NDA has been submitted to a number of countries, including Australia, Singapore, Canada, Mexico, Colombia, South Korea, India, Philippines, etc. Our goal for roxadustat is to serve patients around the world.
Tuba: As anticipated PDUFA date is December 20, 2020, if approved, how it will be helpful for the patients in the US?
Peony Yu: With roxadustat, FibroGen is advancing toward a new standard of care for anemia – an area that has not seen significant progress or the introduction of a new approach in 30 years. Patients are searching for new, convenient, and effective treatment options. If approved, roxadustat will be administered orally, mostly at home, eliminating the risks associated with needle injection and infection exposure with health care facilities and offering the potential for patients to live a more normal life.
Tuba: What are other products in FibroGen’s pipeline and discuss about their targeted indications?
Peony Yu: Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19).
Notably, the U.S. FDA has granted Orphan Drug Designation to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. Pamrevlumab has also received Fast Track designation from the FDA for the treatment of patients with IPF and LAPC. These designations speak to the need for new, safe, and effective treatment options for these serious conditions.
Tuba: Can you provide an overview on the epidemiology of anemia associated with CKD?
Peony Yu: Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin and thus reduced oxygen delivery to the cells in the body, is a common early complication of CKD, affecting approximately 20% of CKD patients. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.
Tuba: Are FibroGen and partners planning to involve in any digital health solution to promote awareness of kidney diseases?
Peony Yu: We do believe digital health technology is a useful tool for promoting disease awareness, patient education, and treatment for patients and health care providers. Our partner AstraZeneca has already started digital applications towards disease awareness of CKD anemia.
Tuba: What next, we can expect from FibroGen to treat chronic and life-threatening conditions?
Peony Yu: FibroGen is pursuing groundbreaking research and science to drive forward a pipeline that may transform the patient experience and create new standards of care in anemia and an array of serious fibrotic conditions.
The company is currently developing roxadustat and continuing clinical development for pamrevlumab.
Tuba: What is FibroGen thinking about the potential benefits of using telehealth and mobile-based health resources to improve care for people with CKD?
Peony Yu: Roxadustat, being the first oral medicine for the treatment of CKD anemia which can be administered in patients’ homes, is conducive for telehealth as patients no longer need to receive treatment via injections in doctors’ offices or hospital infusion centers. There are many potential applications of digital health resources to improve anemia care in CKD patients.
About Peony Yu:
Dr. Peony Yu is Chief Medical Officer of FibroGen and has joined the company in 2008. She oversees all global and regional clinical development strategies and execution of the various clinical programs, as well as providing leadership for the roxadustat program.