- The Food and Drug Administration has granted Roche’s Ocrevus (ocrelizumab) priority review status, setting up the multiple sclerosis drug for an earlier approval than expected, the company said Tuesday.
- Approval was originally anticipated next year, but the FDA now plans to decide on approval by December 28.
- If Ocrevus is approved, it will be the first multiple sclerosis treatment approved for both the relapsing-remitting and primary progressive types of the degenerative disease.
Roche, the world's largest cancer drug maker, is looking to offset patent expiry for several key drugs, including loss of exclusivity for the blockbuster biologic Rituxan in certain markets.
At the same time, the company is determined to maintain a strong presence in neurology, where it has a comparatively strong pipeline.
Approval of Ocrevus, which is designed to address both types of MS, could provide a much-needed boost in that area.
Ocrevus showed better efficacy in head-to-head clinical trials against German Merck's Rebif, and had a solid safety profile.
Approval could set up Ocrevus to hit $3.8 billion in sales by 2022, reports Reuters.
Those estimates are based off of the drug’s efficacy against both the relapsing-remitting and the primary-progressive forms of MS. Although 80 percent of patients suffer only from relapse-remitting MS, the ability to treat both expands the potentially treatable patient population.