EMA/CHMP backs five novel medicines for approval

At its November 11-14 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five novel medicines for marketing approval. The recommendations will now go for final approval from the European Commission, which typically comes within two or three months.

The Committee recommended granting a marketing authorisation for Italian drugmaker Recordati’s (RECI: MI) Isturisa (osilodrostat) for the treatment of Cushing’s syndrome, a rare disorder that occurs when the body produces too much corticosteroid hormone. It leads to patients experiencing weight gain, fat build-up on the face and bruising.

Swiss pharma giant Novartis’ (NOVN: VX) Mayzent (siponimod) received a positive opinion for the treatment of adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.  If approved, Mayzent is expected to be the first and only oral treatment specifically indicated for patients with active SPMS based on a randomized clinical trial of a broad SPMS patient population.