- Roche will have to wait an additional three months to find out whether its multiple sclerosis (MS) drug will make it to market in the U.S., the Swiss biopharma revealed Tuesday.
- The Food and Drug Administration opted to delay its verdict — originally slated for Dec. 28 — on the company's biologics license application for Ocrevus (ocrelizumab) until March 28.
- Patients with MS have immune systems that attack their own central nervous systems, leading to nerve damage. Ocrevus employs monoclonal antibodies that bind to and inhibit CD20-positive B cells, which are thought to contribute to the damage.
The FDA's decision waters down the priority review designation it gave Ocrevus back in June and delays potential market entry for one of the most anticipated drugs in the MS pipeline.
Roche would surely like to lock down an approval for the drug sooner than later. The big biopharma has been banking on new drugs to rejuvenate its pipeline as patent exclusivity begins to run out on big earners like Avastin, Herceptin and Rituxan over the next couple years.
Ocrevus is being investigated as a treatment for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Currently, there are no FDA-approved treatments for the latter indication. Some 2.3 million people around the world suffer from some type of MS, according to the National Multiple Sclerosis Society.
The company presented data from three Phase 3 studies of the drug in September. Efficacy results showed 75% more RMS patients had no evidence of disease activity when taking Ocrevus versus Merck KGaA's Ribuf, while 47% more PPMS patients had no disease progression compared to placebo.
A May report from Grandview Research expects Ocrevus and Biogen's recently approved Zinbryta to "improve usage rates" across the MS market — which hit $20.1 billion in the U.S. in 2015 — in coming years.