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Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical Settings
Posted 29 Dec 2016 by Drugs.com
Lexington, Mass. – December 27, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Adynovate [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA also approved Adynovate for use in surgical settings for both adult and pediatric patients. Adynovate is built on the full-length Advate [Antihemophilic Factor (Recombinant)] molecule, a market leading treatment for hemophilia A with more than 13 years of real-world patient experience. “Physicians need additional treatment options for pediatric patients and those undergoing surgery with hemophilia A,” said lead investigator Eric Mullins, M.D., Research Director, Hemophilia Treatment Center, Cincinnati Children’s Hospital Medical Cent ... Read more
Posted 16 Nov 2015 by Drugs.com
November 13, 2015 – The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding. Adynovate is approved for on-demand (as needed) treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes (prophylaxis) in patients with Hemophilia A. Adynovate consists of the full-length Coagulation Factor VIII molecule (historically known as Antihemophilic Factor) linked to other molecules, known as polyethylene glycol (PEGylated). This link makes the product last longer in the patient’s blood. “The approval of Adynovate provides an important therapeutic opt ... Read more