EU CHMP To Decide On New Drugs For Asthma, Diabetes, Hemophilia A, Ovarian Cancer – And Roche’s Ocrevus
Products for a wide range of diseases are expecting a CHMP opinion this week, including orphan drugs for ovarian cancer, eosinophilic esophagitis, and CMV infection, and therapies for asthma, diabetes, and hemophilia A. Roche will be hoping its multiple sclerosis drug Ocrevus can finally clear the CHMP hurdle.
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Sponsor's proposal for a label warning, but not a black box, on retinopathy risk with the once-weekly GLP-1 agonist finds support from a US FDA advisory committee, which overwhelming endorsed approval for treatment of type 2 diabetes on the basis of robust glycemic control efficacy data and a strong cardiovascular safety profile.
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.
Ten Approvals To Look Out For In Q4
From AstraZeneca’s benralizumab in asthma to Kite Pharma’s CAR-T therapy, Scrip takes a look at some of the more interesting drug approvals expected by the end of the year, with the help of analysts from Informa's Biomedtracker.