Askume, Sept 12 – The U.S. Food and Drug Administration on Thursday approved Roche’s (ROGS) subcutaneous injection to treat patients with multiple sclerosis .
The therapy is approved as a twice-yearly infusion or intravenous injection for multiple sclerosis under the brand name Ocrevus.
Approval of subcutaneous or subcutaneous therapy would help expand its use in treatment centers that are not equipped for intravenous therapy.
Ocrevus is used to treat patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Roche did not immediately respond to a Askume request for information on the launch date and price of the shot version.
Multiple sclerosis is a disease that occurs when the immune system attacks the brain and spinal cord.
Roche estimates that the disease affects more than 2.8 million people worldwide.
RMS is characterized by the onset of new or worsening signs or symptoms followed by periods of recovery. PPMS causes progressive worsening of neurological symptoms and disability without any recurrence or remission.
Tecentrix Hybrezza is a subcutaneous injection given twice a year over 7 minutes, similar to the previously approved intravenous injection.
The approval was based on data from a late-stage study that showed Ocrevus as a subcutaneous injection to be non-inferior to an intravenous injection, based on blood concentration measurements for up to 12 weeks.
The safety and effectiveness of the injectable formulation is also similar to that of the intravenous formulation in patients with RMS and PPMS.
The subcutaneous formulation, which received marketing authorization from the European Commission in June, combines Ocrevus with Halozyme Therapeutics’ (HALO.O) drug delivery technology, allowing the therapy to quickly disperse and be absorbed into the bloodstream.
Ocrevus is a monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a major contributor to nerve cell damage.
According to Roche, more than 350,000 MS patients worldwide have received Ocrevus IV treatment. Sales of the IV formulation of Ocrevus are reported to be CHF 6.38 billion ($7.54 billion) in 2023.
Other approved treatments for RMS include Novartis’ (NOVN.S) Kesimpta, which is given as a monthly injection, and Biogen ‘s (BIIB.O) Tysabri, which is given intravenously every four weeks.
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