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