Ocrevus (ocrelizumab) receives Breakthrough Therapy Designation and plans submission to FDA for primary progressive multiple sclerosis in H1 2016- Genentech/Roche

Genentech, a member of the Roche group announced that the FDA has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (Ocrevus) for the treatment of people with primary progressive multiple sclerosis (PPMS).

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The designation is based on positive results from the pivotal Phase III study (called ORATORIO), which showed treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo. Top-line results were presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015.

Genentech plans to pursue marketing authorization for both PPMS and relapsing multiple sclerosis (RMS), a more common form of the disease, and will submit data from three pivotal Phase III studies to the FDA in the first half of 2016.

Comment: There are currently no approved treatments for primary progressive multiple sclerosis, a debilitating form of MS characterized by steadily worsening symptoms and typically without distinct relapses or periods of remission.