On June 6th, the FDA approves Biogen Idec’s orphan drug Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in both adults and children with Hemophilia A. Eloctate is the first Hemophilia A treatment that results in less frequent injections when used for the reduction or prevention of bleeding, because of its prolonged circulation in the body.
FDA Orphan Drug Designation (ODD) Database Record
| Generic Name: | recombinant human coagulation factor VIII Fc fusion protein |
| Trade Name: | n/a |
| Date Designated: | 11-23-2010 |
| Orphan Designation: | Treatment of hemophilia A |
| Orphan Designation Status: | Designated |
| FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
| Sponsor: | Biogen Idec Hemophilia, Inc. 9 Fourth Avenue Waltham, MA 02451 The sponsor address listed is the last reported by the sponsor to OOPD. |
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According to Biogen Idec’s Press Release, Hemophilia A:
• Occurs in approximately…
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DRUG REGULATORY AFFAIRS INTERNATIONAL 