Genentech’s ocrelizumab has been given a Breakthrough Therapy Designation by the FDA as a potential treatment for primary progressive multiple sclerosis.
Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo.
The FDA designation is intended to speed the development and agency review of medicines aiming to treat serious and life-threatening diseases. Ocrelizumab is the first medicine to show positive pivotal trial results in both PPMS and relapsing MS, a more common form of the disease.
Currently, there are no approved treatments for PPMS, a debilitating disease form characterized by slow onset and steadily worsening symptoms. About 10 percent of the estimated 2.3 million people worldwide with MS have this form of the disease.
“Ocrelizumab is the first investigational medicine for MS to be granted Breakthrough Therapy Designation by the FDA,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a press release. “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.”