Posted by Michael Wonder on 26 Jan 2018
Highlights from January 2018 CHMP meeting
26 January 2018 - Seven medicines recommended for approval, including one orphan.
The EMA's CHMP recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.
The CHMP recommended granting a marketing authorisation for Hemlibra (emicizumab), a first-in-class medicine to prevent bleeding episodes in patients with haemophilia A who have factor VIII inhibitors. This medicine was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest.
The CHMP recommended granting a marketing authorisation for Lamzede (velmanase alfa), a long-term enzyme replacement therapy in adults, adolescents and children with mild to moderate forms of alpha-mannosidosis. Because alpha-mannosidosis is a very rare disease, Lamzede was granted an orphan designation.
The Committee recommended granting a marketing authorisation for Shingrix (recombinant, adjuvanted Herpes zoster vaccine), a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in adults 50 years of age or older.
