FDA approves new drug Eloctate for treating Hemphilia A-

Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has approved ELOCTATE ™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A. ELOCTATE is the first recombinant hemophilia A therapy with prolonged circulation in the body. It is the only treatment for hemophilia A to reduce the frequency of bleeding episodes with prophylactic infusions every three to five days, offering people with hemophilia A the potential to extend the interval between prophylactic infusions.

Today Biogen Idec BIIB +0.58% announced that the U.S. Food and Drug Administration (FDA) has approved ELOCTATE ™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A. ELOCTATE is the first recombinant hemophilia A therapy with prolonged circulation in the body. It is the only treatment for hemophilia A to reduce the frequency of bleeding episodes with prophylactic infusions every three to five days, offering people with hemophilia A the potential to extend the interval between prophylactic infusions.

The recommended starting prophylactic regimen for ELOCTATE is 50 IU/kg every four days. Based on clinical response, the regimen may be adjusted in the range of 25 to 65 IU/kg and every three to five days.

In clinical trials, ELOCTATE was effective for both routine prophylaxis and to treat acute bleeding episodesFingolimod with a favorable safety and tolerability profile. It was developed using a process called Fc fusion, which is designed to prolong the therapy’s circulation in the body using a natural pathway. The FDA’s approval is the first regulatory approval worldwide for ELOCTATE, and the therapy is currently under review by regulatory authorities in several other countries, including Canada, Australia and Japan. This FDA action follows regulatory approvals of Biogen Idec’s hemophilia B therapy, ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein], in the United States, Canada and Australia.

Therapies for hemophilia A, the most common form of hemophilia, can be administered either on a schedule to help prevent or reduce bleeding episodes (prophylaxis), or to control bleeding when it occurs (on-demand). The NHF recommends routine Imatinibprophylaxis as optimal for the treatment of people with severe hemophilia. In recent years, regimens have shifted from on-demand treatment to routine prophylaxis because of observed improvement in long-term clinical outcomes, such as joint damage.

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