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.

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).

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