Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Biogen Submits BLA For First Long-Lasting Factor VIII Therapy For Hemophilia A

RELATED NEWS
Trade BIIB now with 

Biogen Idec (BIIB: Quote) reported submitting a Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for the marketing approval of recombinant factor VIII Fc fusion protein or rFVIIIFc to treat hemophilia A. Recombinant FVIIIFc is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for this condition.

If approved, rFVIIIFc would be the first major advance in hemophilia A treatment in more than two decades, according to the company. The regulatory submission was based on results from A-LONG, the largest registrational phase 3 trial in hemophilia A to date.

Biogen Idec added, "In our phase 3 study, patients treated with rFVIIIFc were able to inject rFVIIIFc once-weekly to twice-weekly, which creates the potential for those currently on prophylactic treatment to reduce injections by 50 to 100 per year. Moreover, patients currently treating bleeding episodes could potentially dose prophylactically once per week and maintain significant protection from bleeding with about the same total number of injections each year they use to treat bleeding episodes today."

On March 4, 2013 Biogen Idec announced the FDA accepted for review the company's BLA for its factor IX candidate, rFIXFc, for use in patients with hemophilia B.

Register
To receive FREE breaking news email alerts for Biogen Idec and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Consumers spent less in July than in the previous month, a surprise retreat that complicates the prevailing belief that the U.S. economic situation is improving. Along with the unexpected drop in spending, government figures released on Friday showed that incomes rose at a slower pace in July than in the previous month. Meanwhile, data on prices indicated that inflation pressures remain tame. India's economy grew faster-than-expected in the three months to June and at the strongest pace in two years, preliminary figures from the Central Statistics Office revealed Friday. Gross domestic product grew 5.7 percent in the April to June quarter, which exceeded economists' forecast for 5.5 percent expansion. The economy grew 4.6 percent in the previous three months. Eurozone inflation slowed as expected in August on falling energy prices giving room for the central bank to support demand and economic recovery without stoking inflation and help the region to create more jobs. The unemployment rate remained unchanged at an elevated level in July. Nonetheless, it was at the lowest since September 2012.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.