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Experimental MS Therapy Undergoes Speedy Review

June 28, 2016

Ocrevus, Roche/Genentech’s drug under priority review, is an investigational humanized monoclonal antibody that is designed to selectively target CD20-positive B cells, which is a specific type of immune cell that is thought to be a key contributor to myelin and nerve cell damage. This ultimately has the ability to lead to disability in those with multiple sclerosis.

It was found from the OPERA I and OPERA II Phase III trials which involved patients with relapsing MS that the drug had beat Rebif (interferon beta-1a) in reducing the three main markers of disease activity over a two-year period. A 46 and 47 percent reduction in the annualized relapse rate was shown as well as a 43 and 37 percent risk reduction that was confirmed in disability progression for 12 weeks in comparison to interferon beta-1a.

Genentech’s biologic considerably ‘slashed’ the progression of clinical disability by 24 percent for at least 12 weeks which was the primary endpoint of the Phase III ORATORIO trial. 25 percent in over 24 weeks resulted in the same way, this was the secondary endpoint.

Roche’s chief medical officer and head of Global Product Development, Sandra Horning said, “Ocrevus is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS.” She also said they believe Ocrevus has the potential to aid those living with these forms of MS.


http://www.pharmatimes.com/news/speedy_review_for_rochegenentechs_ms_drug_ocrevus_1049483