) recently submitted a Biologics License Application (BLA) in the
US for its multiple sclerosis candidate, Plegridy (peginterferon
beta-1a). The company is looking to gain US Food and Drug
Administration approval for Plegridy for relapsing forms of
multiple sclerosis (RMS).
The BLA submission was based on results from the first year of
the two-year global phase III ADVANCE study. Plegridy was
compared to placebo in the study. Plegridy (dosed once in two
weeks) met the primary endpoint of annualized relapse rate (ARR)
at one year. ARR reduction was 36% compared to placebo.
Secondary endpoints included reduction of the risk of 12-week
confirmed disability progression as measured by the Expanded
Disability Status Scale (by 38%), reduction in the proportion of
patients who relapsed (by 39%) and reduction in the number of new
or newly enlarging T2-hyperintense lesions on brain MRI scans (by
67%) compared to placebo. The number of gadolinium-enhancing
(Gd+) lesions was reduced by 86% in the Plegridy arm.
These results were presented at the annual meeting of the
American Academy of Neurology. While a once-in-four weeks dosing
regimen of Plegridy was also evaluated in the study, the once-
every-two weeks dosing arm was more effective.
Biogen intends to file for EU approval shortly.
We are pleased with Biogen's progress with its multiple
sclerosis pipeline. A less frequent dosing schedule and a
favorable safety and efficacy profile should work in Plegridy's
favor once it is launched.
Biogen is the market leader in therapies for the treatment of
multiple sclerosis. We believe the company will continue to
retain a leading position in the multiple sclerosis market.
Biogen received a major boost with its oral multiple sclerosis
drug, Tecfidera, gaining FDA approval. We believe Tecfidera could
become a leader in the oral multiple sclerosis market. Biogen has
another multiple sclerosis candidate, daclizumab, in development
Biogen is currently a Zacks Rank #3 (Hold) stock. Companies
that look well-positioned include
Anika Therapeutics Inc.
). While Anika is a Zacks Rank #1 (Strong Buy) stock, Alkermes is
a Zacks Rank #2 (Buy) stock.
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