Two new medicines recommended for approval by EMA's CHMP

As a result of its July meetings, the European Medicines Agency’s Committee for Medicinal Products for Human has recommended just two novel medicines for approval and rejected one.

The Committee adopted a positive opinion for Nexviadyme (avalglucosidase alfa), intended for the treatment of glycogen storage disease type II (Pompe disease), from Genzyme, a unit of France’s Sanofi (Euronext: SAN).

The benefit of Nexviadyme is its ability to improve the respiratory function (also called force vital capacity) of Pompe disease patients. The most common side effects are hypersensitivity (including anaphylaxis), infusion associated reactions (pruritus, rash, headache, urticaria, fatigue, nausea and chills).