Wednesday, 22 May 2013

Biogen-Idec submits application to FDA for Peg-interferon beta-1a in MS

Biogen Idec announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of peginterferon beta-1a, a pegylated subcutaneous injectable candidate for relapsing forms of MS.This regulatory submission was based on the results from the first year of the two-year global Phase 3 ADVANCE study. The data demonstrated that peginterferon beta-1a 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 to the BLA filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for peginterferon beta-1a to the European Medicines Agency (EMA) in the coming weeks.
Peginterferon beta-1a 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. Peginterferon beta-1a s 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.

The two-year Phase 3 ADVANCE clinical trial is a global, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy and safety of peginterferon beta-1a in 1,516 patients with relapsing-remitting MS.





"Why did Biogen-Idec go for the subcutaneous route, when their other compound is so well tolerated as an intramuscular preparation?"

"Is there space in the market for another interferon? Would you go for an injection every 2 or 4 weeks, over a weekly or more frequent injection?"


For full article: Business Wire 05/21/2013 4:30 AM ET

Other posts of interest on this topic:


30 Dec 2011
PEGylation of Interferon-β-1a: A Promising Strategy in Multiple Sclerosis. CNS Drugs. 2011 Dec 23. Biological ... A PEGylated form of interferon-β-1a (PEG-IFNβ-1a) is being developed for MS. Phase I study data suggest that ...
26 Jan 2013
Peginterferon beta-1a 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. The ADVANCE study ...

CoI: multiple, The Royal London Hospital was a site in the ADVANCE study.

3 comments:

  1. Flogging if not a dead horse, a terminally ill one? Seems to me they're just trying to squeeze the last drops of profit out of something that's time has passed.

    ReplyDelete
  2. Probably I couldn't, as my liver enzymes levels (TGO/TGP) were up high (over 1000) under use of interferon beta 1a. In this peginterferon I would have the same side effect, ain't I?
    Tiago

    ReplyDelete
  3. Modify an existing compound : baclofen vs arbaclofen, add peg molecule to interferon (pegylated interferon is/has been used for quite a while for hep C infection). Agreed, sounds a little like coke tweaking their product.

    ReplyDelete

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