Ocrevus Delay As CHMP Continues Assessment?
The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.
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Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up
Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.
Roche Lifts Outlook, Spotlights Perjeta To Drive Growth
A “phenomenal” start by Ocrevus and the use of two other newly launched medicines, Tecentriq and Alecensa, drove sales growth at Roche in the first half of 2017 – with the previously cautious company now upgrading its financial outlook for the year and expecting further growth from breast cancer therapy Perjeta.
Genentech's Ocrevus Manufacturing Process Still A Work In Progress
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.