logo
Share SHARE
FONT-SIZE Plus   Neg

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

Biogen Idec (BIIB) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
They say there's plenty of fish in the sea, but very few of them are as wealthy as these tycoons. May be they have been so busy building their empires they never had the time to stick with a perfect partner to build their family. This list of the richest singles is assorted — from a 34 year-old... Anthony Levandowski, the head of Uber's self-driving division, is stepping away from his role as Uber continues a legal battle with Waymo, Levandowski's former employer. Levandowski, who founded startup Otto, became head of Uber's Advanced Technologies Group or ATG after Otto was acquired by Uber in August 2016. Southwest Airlines Co. has decided to end the practice of overbooking flights, the airline's CEO Gary Kelly said Thursday. The airline's plan to end overbooking could be implemented from May 8, according to a Southwest spokeswoman.
comments powered by Disqus
Follow RTT