‘Surprised and Disappointed’ Santhera To Fight EU’s DMD Rejection
Santhera has vowed to appeal against this week’s recommendation by the European Medicines Agency that the company’s application to extend Raxone’s indication to cover DMD be rejected. The agency recommended EU approval for four other drug applications seeking extended indications.
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The first meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London, with a number of new drugs up for a marketing authorization recommendation.
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.
Just three initial marketing authorization applications are up for an opinion this week on whether they should be approved for sale across the EU. Roche’s new multiple sclerosis treatment, Ocrevus (ocrelizumab), is one, after failing to secure a positive opinion earlier. The October meeting of the panel that will decide, the European Medicines Agency’s CHMP, is under way in London.