Posted by Michael Wonder on 10 Nov 2017
Highlights from the CHMP 6-9 November 2017 meeting
10 November 2017 - Ten medicines recommended for approval, including two orphans
The European Medicines Agency’s CHMP recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting.
The CHMP recommended granting a marketing authorisation for Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the oesophagus. This medicine was reviewed under EMA’s accelerated assessment mechanism, reserved for medicines of major public health interest. Jorveza has an orphan designation.
The Committee recommended granting a marketing authorisation for Prevymis (letermovir), an antiviral medicine that prevents cytomegalovirus reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic haematopoietic stem cell transplant. Prevymis has an orphan designation.
The CHMP recommended granting a marketing authorisation for Ocrevus (ocrelizumab), for the treatment of adult patients with relapsing multiple sclerosis and early primary progressive multiple sclerosis.
