STAT+: FDA approves Roche's injectable version of blockbuster multiple sclerosis drug

Swiss pharma giant Roche won approval from the Food and Drug Administration on Friday for an injectable version of its blockbuster multiple sclerosis therapy Ocrevus, cutting down the time needed to treat patients and potentially staving off growing competition.

The approval was driven by the results of a late-stage trial, OCARINA II, in which the company showed that delivering Ocrevus as a 10-minute injection beneath the skin worked as well as the current approach, an hours-long intravenous infusion.

David Jones, medical director at Roche subsidiary Genentech, told STAT that the injectable drug should be available starting in October. The announcement means multiple sclerosis patients will be able to get the treatment in neurologist’s offices and won’t need to travel to specialized infusion centers. The approval could also help Roche fend off competing multiple sclerosis products from Novartis and TG Therapeutics.

Continue to STAT+ to read the full story…