FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Roche Primary Progressive MS Drug Proves Effective in Phase 3 Study

Oct. 6, 2015

Roche’s ocrelizumab proved effective in treating primary progressive multiple sclerosis in a Phase 3 study, making it the first investigational drug to show positive results for both PPMS and relapsing remitting MS.

The 732-patient study met its primary endpoint, showing ocrelizumab significantly reduced the progression of clinical disability in patients with PPMS and sustained it for at least 12 weeks, compared with placebo.

Earlier this year, Roche announced positive results from two Phase 3 studies pitting ocrelizumab against the standard care in patients with relapsing MS, the most common form of the disease.

The Swiss drugmaker plans to submit the data to global regulatory authorities early next year for approval of both indications. — Jonathon Shacat