RESEARCH TRIANGLE PARK, N.C. – Biogen Idec (NASDAQ: BIIB) announced Monday that the U.S. Food and Drug Administration (FDA) has approved Eloctate for the control and prevention of bleeding episodes 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.

In clinical trials, Eloctate was effective for both routine prophylaxis and to treat acute bleeding episodes 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 in the United States, Canada and Australia.

Hemophilia A is a rare, chronic, genetic disorder in which the ability of a person’s blood to clot is impaired. This can lead to recurrent and extended bleeding episodes.

The approval of Eloctate is based on results from the global, Phase 3 A-LONG clinical study, as well as interim pharmacokinetic, or PK, and safety data from the Phase 3 Kids A-LONG study. PK is the measurement of the presence of the therapy in a person’s body over time.

Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females, affecting about 16,000 people in the United States. The World Federation of Hemophilia global survey in 2012 estimates that approximately 142,000 people worldwide are identified as living with the disorder.

Biogen Idec plans to make Eloctate commercially available in the United States in July 2014.