U.S. FDA approves J&J’s multiple sclerosis treatment; launch in April
(Reuters) – Johnson & Johnson will launch its newly approved drug for adults with relapsing multiple sclerosis (MS) in the United States in early April 2021 at a similar price point to rival treatments, the company’s unit said on Friday.
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. (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.
FILE PHOTO: The company logo for Johnson & Johnson is displayed on a screen at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid
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.
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