Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Biogen Idec Submits BLA To FDA For Approval Of Plegridy In Multiple Sclerosis

RELATED NEWS
Trade BIIB now with 

Biogen Idec (BIIB: Quote) announced that it has submitted a Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for approval of Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis or RMS.

The company stated that the regulatory submission was based on the results from the first year of the two-year global Phase 3 Advance study. The data demonstrated that Plegridy met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.

In addition, the company said it plans to submit a Marketing Authorisation Application or MAA for Plegridy to the European Medicines Agency or EMA in the coming weeks.

The company noted that it anticipates hearing from regulatory authorities regarding the status and acceptance of these submissions within the next couple of months.

Plegridy is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule. Plegridy is a member of the interferon class of treatments and, if approved, would be a new addition to this class, which is often used as a first-line treatment for MS.

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

Editors Pick
Apple Inc. said Tuesday after the markets closed that its third quarter profit rose 12% from last year, as sales surged and margins improved amid strong sales of its iPhones and Mac computers. The company's quarterly earnings per share also came in above analysts' expectations, but its quarterly sales fell short of analysts' forecast. United Nations Secretary-General Ban Ki-moon on Tuesday urged both Israelis and Palestinians to stop the fighting that has been raging for the past two weeks in the Gaza Strip, and pleaded with the two sides to return to dialogue with the aim of addressing the underlying causes of the repeated cycles... After moving notably higher in early trading on Tuesday, stocks continued to perform well throughout the session. The gains on the day offset the modest weakness that was seen in the previous session, extending the recent back-and-forth movement by the markets.
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.