EMA's CHMP backs five novel meds for approval; rejects one

At its October monthly meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval.

The CHMP adopted a positive opinion for Swiss firm Santhera Pharmaceuticals (SIX: SAAN) Agamree (vamorolone), for the treatment of Duchenne muscular dystrophy, a genetic disorder characterized by the progressive loss of muscle function. A marketing authorization decision from the European Commission is expected within around two months of the positive CHMP opinion. Subject to approval, Agamree will be the first and only medicinal product fully approved by the EMA for the treatment of DMD.

The committee recommended granting a conditional marketing authorization for Elrexfio (elranatamab), from US pharma giant Pfizer (NYSE: PFE), for the treatment of adult patients with relapsed or refractory multiple myeloma, a rare cancer of the bone marrow that affects plasma cells, a type of white blood cell that produces antibodies. This medicine was supported through EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs.