FDA accepts NDA to review Affymax, Takeda chronic kidney disease drug
The US Food and Drug Administration (FDA) has accepted for reviewing Affymax and Takeda Global Research & Development Center's new drug application (NDA) for peginesatide (Hematide) as a treatment for anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.
Peginesatide, a synthetic, PEGylated peptidic compound, is a erythropoiesis stimulating agent (ESA) that binds and activates the erythropoietin receptor.
The NDA submission is based on data from two Phase 3 studies (Emerald 1 and 2) which evaluated the efficacy and safety of peginesatide.
The study compared once-monthly peginesatide with epoetin in maintaining Hb levels in CKD patients on dialysis with anemia.
Latest News
Related News
Related Sectors
Regulatory Affairs
Related Dates
2011> July
Related Industries
Pharmaceuticals and Healthcare
Regulatory Affairs
Related Dates
2011> July
Related Industries
Pharmaceuticals and Healthcare
Related Insight
Suppliers Directory
Fuld & Company – Competitive Intelligence and Strategic Gaming
Fuld & Company, the global leader in competitive intelligence, delivers customised research and analysis on markets, competitors, suppliers and customers.
Regulatory Affairs > Suppliers
A-Consult - Professional Regulatory Affairs and Drug Safety Services
A-consult offers professional assistance to the pharmaceutical industry within all areas of Regulatory Affairs and Drug Safety.
Regulatory Affairs > Suppliers
Diapharm – Regulatory Affairs, Clinical Development, Quality Management, Business Development
Diapharm GmbH & Co. KG is an international full-service provider to the healthcare industry. Our activities focus on medicinal products, food supplements, medical devices and cosmetics.
Regulatory Affairs > Suppliers
The Chartered Quality Institute - Placing Quality at the Heart of Every Organisation
The Chartered Quality Institute is the chartered body for quality management professionals. With over 10,000 members, a large proportion of those from the pharmaceutical sector, the CQI exist to benefit the public by advancing education in, knowledge of and the practice of quality in industry, commerce, the public sector and the voluntary sectors.
Regulatory Affairs > Suppliers
Production & Manufacturing
Fine & Speciality Chemicals
Manufacturing
Process & Production
OTC
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
Regulatory Affairs Intelligence
Medical Affairs at the Centre of Life Science Innovation
Published by Kinapse
Regulatory Affairs > White Papers
Silicone Oil in Pharmaceutical Products
Published by Toxikon Europe PBR
Regulatory Affairs > White Papers
The Future of Glass as Parenteral Primary Packaging: Issues and Challenges
Published by Parenteral Drug Association (PDA)
Regulatory Affairs > White Papers
Buy the latest industry research online today!
African Pharmaceutical Directory 2013
API research into pharmaceutical companies and corporations Buy online from $200
API research into pharmaceutical companies and corporations Buy online from $200

Comments may be moderated for spam, obscenities or defamation.