Posted by Michael Wonder on 17 Dec 2017
Highlights from December 2017 CHMP meeting
15 December 2017 - Seven medicines recommended for approval, including an advanced therapy.
The EMA's CHMP recommended seven medicines for approval at its December 2017 meeting, including two orphan medicines1, one of which is also an advanced therapy medicinal product (ATMP).
The CHMP recommended granting a marketing authorisation for the ATMP Alofisel (darvadstrocel), for the treatment of complex perianal fistulas in patients with Crohn’s disease. Alofisel has an orphan designation. For more information, please see the press release in the grid below.
The Committee recommended granting a paediatric-use marketing authorisation (PUMA) for Alkindi (hydrocortisone), for the treatment of primary adrenal insufficiency, a rare hormonal disorder in infants, children and adolescents. PUMAs can be granted for medicines which are already authorised but no longer under patent protection, and have been developed specifically for children.
