European Approval Recommendation Delayed Again For Roche’s Ocrevus
No European approval recommendation for Roche multiple sclerosis drug Ocrevus but the Swiss major tells Scrip it is hopeful of getting approval within four months.
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The EMA’s scientific committee, the CHMP, has given the green light to new treatments for multiple sclerosis, eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as the EU’s first biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products have been withdrawn from the assessment process.
Reps. Cummings and Welch contact seven manufacturers of multiple sclerosis drugs with inquiries about persistent and significant annual price increases. The members suggest some firms are boosting prices in "lockstep."
Genentech overcame objections from US FDA quality reviewers to win approval of Ocrevus for multiple sclerosis by adding release and stability testing and committing to resolving process control issues, while suspending plans to accelerate post-approval manufacturing changes.