Roche touts efficacy of MS drug despite delays

Dive Brief:

  • Swiss pharma giant Roche continued to burnish the profile of its closely watched multiple sclerosis (MS) drug Ocrevus (ocrelizumab), touting more complete data from three Phase 3 studies which were published this week in The New England Journal of Medicine.
  • Detailed analysis of the studies showed Ocrevus reduced markers of disease activity and progression compared with either Rebif (interferon beta-1a) in relapsing MS or placebo in primary progressive MS. 
  • All three studies had met their primary endpoints, setting up Roche's submission of the drug for approval earlier this year. The FDA, however, recently extended its review period for Ocrevus, pushing a decision on approval to March 28 from December. 

Dive Insight:

The results published in NEJM (here and here) help complete the picture on Ocrevus' efficacy and safety in the two forms of MS. Ocrevus has attracted attention due to its effectiveness in treating primary progress MS (PPMS) as well as relapsing MS (RMS). There are currently no drugs approved to treat PPMS. 

In two studies testing Ocrevus in relapsing multiple sclerosis, treatment reduced the annual relapse rate by nearly 50% in both compared to inferferon beta-1a. Ocrevus also reduced the risk of confirmed disability progress (CDP) by 43% and 37% in the two studies compared to interferon, sustained across 24 weeks. 

The third Phase 3 study on the other hand, testing Ocrevus in PPMS, showed a 25% relative risk reduction in CDP compared to placebo, sustained for at least 24 weeks.

Safety data was comparable between both Ocrevus and interferon as well as between Ocrevus and placebo. 

The FDA's delay is a bit of a sting in the tail end of the year for Roche, however. Ocrevus had been granted priority review back in June 2016, but the extension will almost entirely offset the sped-up priority review timeline. Roche's drug also faces competitive threats, with Biogen and AbbVie's Zinbryta (daclizumab) approved in May 2016 and Novartis experimental S1P receptor modulator progressing in Phase 3 trials.

Roche indicated the extension was tied to the commercial manufacturing process for Ocrevus, rather than the drug's safety or efficacy profile. 

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Filed Under: Clinical Trials
Top image credit: Roche