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CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin

 
• By Ian Schofield

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 The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.

Recommendation
The CHMP has recommended 10 new products for EU approval.

The European Medicines Agency’s main scientific committee, the CHMP, has given positive opinions on ten new products, including AstraZeneca PLC’s Fasenra (benralizumab) for eosinophilic asthma, Dr Falk’s Jorveza, a budesonide-containing orphan drug for esosinophilic esophagitis that underwent an accelerated assessment procedure, and – at last – Roche’s Ocrevus (ocrelizumab) for multiple sclerosis.

Other products OKd at the committee’s monthly meeting last week included Merck Sharp & Dohme Ltd

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