Posted by Michael Wonder on 27 Apr 2019
Meeting highlights from the CHMP 23-26 April 2019
26 April 2019 - EMA’s human medicines committee recommended thirteen medicines for approval at its April 2019 meeting.
The Committee recommended granting a marketing authorisation for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months.
Two orphan medicines received a positive opinion from the CHMP: Esperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency), and Ultomiris (ravulizumab), for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.
