Ocrevus should be available as a 10-minute injection starting in October

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.

Ocrevus is approved to treat relapsing and primary progressive forms of multiple sclerosis, an autoimmune disease that damages nerve fibers throughout the brain and spinal cord. The drug is an antibody that latches onto CD20, a molecule made by B cells, a type of immune cell. It’s Roche’s best-selling product, and brought in more than $7 billion in sales last year.

Patients need two infusions a year, and each of those appointments can last up to six hours. To cut that time down, Roche partnered with Halozyme, a San Diego biotech focused on drug delivery. The company has developed a technology that breaks down sugar molecules in the skin so that intravenous drugs can be delivered as injections.

https://www.statnews.com/2024/09/13/fda-approves-roche-injectable-multiple-sclerosis-drug-ocrevus/