EMA Recommends EU Approval for Six Drugs, Including Three Orphan Drugs

March 30, 2017

The EMA’s Committee for Medicinal Products for Human Use is recommending EU approval of six drugs for treating a range of conditions from rare forms of cancer to chronic heart failure.

The CHMP recommended Apeiron Biologics’ Dinutuximab beta Apeiron under the condition that the company would commit to post-authorization obligations and monitoring.

The two other orphan drugs are Novo Nordisk’s Refixia, for the treatment of bleeding in hemophilia B patients, and Bene-Arzneimittel’s Elmiron, for the treatment of bladder pain syndrome due to glomerations or Hunner’s lesions.

Pfizer’s meningococcal vaccine Trumenba, which prevents invasive meningococcal disease caused by meningococcal serogroup B bacteria, also received CHMP’s backing.

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