Roche Finally Gets EU CHMP OK For Ocrevus Amid Access Concerns
The Swiss major has finally been granted a positive opinion for Ocrevus but a patient group is concerned that the proposed label will not mean access for many patients with primary progressive multiple sclerosis.
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CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin
At its November meeting, the CHMP finally OKd Roche's Ocrevus for multiple sclerosis and gave the green light to new drugs for eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as Amgen’s Mvasi, the first EU biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.
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.
Partner Or Go It Alone? TG Therapeutics Ponders EU Plans For Briumvi
TG Therapeutics has successfully launched Briumvi on its own in the US, despite fierce competition from established same-class MS drugs Ocrevus and Kesimpta, but is still weighing up the pros and cons of partnering for the European market.