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
Anglo-Dutch oil giant Royal Dutch Shell plans to cut 2,200 more jobs, as the company continues to face lower oil prices, media reported Wednesday citing an emailed statement. The latest round of cuts would bring the total job cuts this year to at least 5,000 globally. In the U.K. and Ireland, the company plans to reduce staff working in exploration and production by 475. Tiffany & Co. (TIF) reported first-quarter net earnings of $87 million, or $0.69 per share compared to $105 million, or $0.81 per share, in the prior year. The company noted that its first-quarter results included a tax benefit of $0.05 per share related to the settlement of a tax examination. On average,... Shares of Marks & Spencer Group plc were losing around 8 percent in the early morning trading in London, after the retailer reported lower profit in its fiscal 2016, hurt mainly by weak results at clothing & Home segment and lower UK LFL sales. Looking ahead, the company warned about profit, and said it sees a similar sales trend in fiscal 2017.
comments powered by Disqus
Follow RTT