- Roche's much-anticipated multiple sclerosis drug Ocrevus (ocrelizumab) helped limit disease activity in more patients with the relapsing forms of the autoimmune disease than Merck KGaA's Rebif, post-hoc analyses of two Phase 3 studies showed.
- Additionally, Ocrevus beat out a placebo in halting disease progression among patients with primary progressive multiple sclerosis (MS), as measured by a composite endpoint used in an analysis of a third Phase 3 trial. There are currently no drugs approved to treat primary progressive MS.
- Roche hopes to win approval for Ocrevus in the U.S. by late December — a quicker timeline than previously expected after the Food and Drug Administration decided in June to grant priority review for the experimental drug.
If approved, Roche's Ocrevus could win substantial market share in the MS market. It would be the first approved drug to treat both relapsing and primary progressive forms of MS, which are estimated to affect as much as 95% of people diagnosed with the disease.
According to forecasts reported by Reuters, estimated annual sales of Ocrevus in 2022 are pegged at over $4 billion. That lofty forecast is tied to its potential to treat two forms of MS.
Initially reported data from the two Phase 3 studies comparing Ocrevus to German Merck's Rebif in relapsing MS (RMS) showed Ocrevus was superior in reducing annualized relapse rates and disability progression.
The recently announced post-hoc analyses of those trials used a new composite endpoint, known as No Evidence of Disease Activity (NEDA), to further measure disease control. Over 96 weeks, treatment with Ocrevus "significantly increased the proportion of RMS patients achieving NEDA by 75%," compared to Rebif.
Over 60% of patients achieved NEDA — which is defined by no relapses, no confirmed disability progression, and no new or enlarging MRI lesions — after 6 months of treatment with Ocrevus.
Roche also used another composite endpoint to measure disease control in its post-hoc analysis of the third Phase 3 trial among patients with primary progressive MS (PPMS). Ocrevus showed greater efficacy, compared to placebo, in this measurement as well.
Further data from these studies will be presented at the 32nd meeting of the Europe Committee for Treatment and Research in Multiple Sclerosis, currently underway in London.
In addition to the expected FDA decision, Roche is awaiting a decision on approval from European regulators, who accepted Roche's marketing authorization application for Ocrevus in June.
Merck KGaA's Rebif is the top-selling drug for the German drugmaker, pulling in nearly €1.8 billion in sales last year. That number was down almost 11%, however, due to a "difficult competitive environment" in the MS market. Rebif is only approved to treat relapsing forms of MS and an approval for Ocrevus could further dent its fortunes.