FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EMA’s CHMP Recommends Seven Medicines for Approval, Including One Cell Therapy

Dec. 20, 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy.

The CHMP recommended Tigenix’s Alofisel (darvadstrocel), for the treatment of complex perianal fistulas in patients with Crohn’s disease. Alofisel is composed of expanded adipose stem cells that impair white blood cells and can reduce inflammation, regulating the body’s immune system response to allow the tissues around the fistula to heal.

Kyowa Kirin’s Crysvita (burosumab) was recommended for conditional approval in X-linked hypophosphataemia with evidence of bone disease in children with growing skeletons — an inherited genetic disorder characterized by low phosphate levels. Crysvita also received an orphan designation. The recommendation was based on two Phase II studies, and a conditional approval would require additional clinical data in the future.

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