Roche MS drug granted FDA Breakthrough status

The US Food and Drug Administration has granted Breakthrough Therapy designation for Roche’s (ROG: SIX) investigational medicine Ocrevus (ocrelizumab) in primary progressive multiple sclerosis (PPMS).

There are no existing approved treatments for PPMS, a debilitating form of MS characterised by steadily worsening symptoms and typically without distinct relapses or periods of remission.

Sandra Horning, Roche’s chief medical officer and head of global product development, said: “Ocrelizumab is the first investigational medicine for MS to be granted Breakthrough Therapy Designation by the FDA. With no approved treatments for primary progressive MS, ocrelizumab has the potential to address an important unmet need. We are committed to working with the FDA to bring ocrelizumab to people with primary progressive MS as quickly as possible.”