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Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up

 
• By Maureen Kenny

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.

The question mark in a number of
The CHMP still has questions for Roche on Ocrevus • Source: Shutterstock

Just one product – Tacforius, a generic tacrolimus from Teva for the prophylaxis and treatment of transplant rejection – got a positive opinion from the European Medicines Agency’s CHMP this month.

The committee delivered no opinion on the other two initial marketing authorization applications that it was considering with a view to potentially recommending them for approval across the EU: Roche’s new multiple sclerosis treatment, Ocrevus (ocrelizumab), and a second generic product,

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