EMA's CHMP recommends five new drugs at its December 2017 meeting

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines for approval at its December 2017 meeting, including two orphan medicines, one of which is also an advanced therapy medicinal product (ATMP), and one biosimilar.

The CHMP’s opinions will now be sent to the European Commission (EC) for final review, which is normally expected within two or three months.

The CHMP recommended granting a marketing authorization for the ATMP Alofisel (darvadstrocel), from Takeda Pharmaceutical (TYO: 4502) and TiGenix (Euronext Brussels: TIG), for the treatment of complex perianal fistulas in patients with Crohn’s disease. Alofisel has an orphan designation. This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe, according to the companies.

The Committee recommended granting a pediatric-use marketing authorization (PUMA) for Alkindi (hydrocortisone), from Diurnal Group (AIM: DNL), 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 authorized but no longer under patent protection, and have been developed specifically for children.