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 With the approval, the drugmaker enters a market currently dominated
by big names like Roche's Ocrevus, Novartis' Kesimpta and Gilenya,
and Biogen's top-selling drug Tecfidera.
The U.S. Food and Drug Administration on Friday approved J&J's
treatment, Ponvory, as a daily oral drug to treat relapsing forms of
MS, Janssen Pharmaceutical Co said. (https://refini.tv/3c1kjcz)
Multiple sclerosis is a debilitating neurological condition in which
the immune system eats away at the protective covering of nerves.
J&J is pushing Ponvory as a once-daily oral treatment, as opposed to
Kesimpta, which is injected by patients at home, or Ocrevus that is
administered as an infusion in a clinic or hospital.
The approval will be cause of concern for Biogen, as it is facing
Tecfidera patent expiration and increasing competition in the MS
landscape.
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 The FDA approval was based on
data from a two-year late-stage study where
Ponvory demonstrated superior efficacy in
significantly reducing annual relapses by about
30% compared to Sanofi's approved MS drug
Aubagio, the company said.
The drug has also outdone Aubagio at reducing
fatigue among patients.
J&J acquired Ponvory as part of its $30 billion
buyout of Swiss biotech company Actelion in
2017, to diversify its drug portfolio as its
biggest product, Remicade for arthritis, faced
cheaper competition.
Ponvory is also under review by the European
Medicines Agency (EMA).
(Reporting by Mrinalika Roy in Bengaluru;
Editing by Shailesh Kuber)
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