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FDA Approves Yet Another ORAL Tx for MS – Ponvory


Last week the FDA approved a new ORAL therapy, Ponvory (ponesimod) from Janssen Pharmaceutical, to treat relapsing forms of Multiple Sclerosis.

There is no shortage of therapy options that cover the full spectrum of routes of administration….. oral – subQ – infused…. from a host of manufacturers. Ponvory will face stiff market competition now dominated by big names like Roche’s Ocrevus, Novartis’ Kesimpta and Gilenya, and Biogen’s Tecfidera.

Janssen did not disclose pricing but did say that the cost of Ponvory will be comparable to other market leader products which are now priced in the $7,000 – $10,000 per month range.

Janssen is promoting superior efficacy as the reason that prescribers and patients should turn to Ponvory. But, Ponvory will be slotted on payer formularies along side other MS therapies. Those patients paying copays for their MS treatment may see no financial benefit in making a switch. Similarly, a patient paying a coinsurance for a comparably priced therapy may see little out of pocket difference. However, it will be interesting to see if payers include Ponvory in their ‘preferred brand drug’ tier. Usually that is driven by the size of the rebate to the payer.

Janssen did not disclose whether Ponvory will launch through limited distribution. Our data indicates that virtually all leading MS therapies are currently only available through limited distribution.

FDA approves J&J’s multiple sclerosis treatment

March 19 (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.

The U.S. Food and Drug Administration on Friday approved J&J’s treatment, Ponvory, treat relapsing forms of MS, Janssen Pharmaceutical Co said.

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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