EMA Highlights: New medicines granted EU approval

by Gary Finnegan: The European Medicines Agency (EMA) has recommended approval of several new medicines.

A number of the products approved by the influential Committee for Medicinal Products for Human Use (CHMP) are for the treatment of respiratory illnesses:

–         Anoro (umeclidinium bromide/vilanterol) and Laventair (umeclidinium bromide/vilanterol), as well as Incruse (umeclidinium bromide) and Ulunar Breezhaler (indacaterol / glycopyrronium bromide), are intended for the treatment of symptoms in adult patients with COPD.

–         DuoResp Spiromax (budesonide / formoterol) and BiResp Spiromax (budesonide / formoterol), are intended for the treatment of asthma and COPD.

Other therapeutic areas:

–         Vimizim (elosulfase alfa) was granted marketing authorisation by the CHMP for the treatment of mucopolysaccharidosis type IVA. Vimizim has an orphan designation.

–         Vokanamet (canagliflozin/metformin) for the treatment of type 2 diabetes.

–         Pregabalin Pfizer (pregabalin) for the treatment of neuropathic pain, epilepsy and general anxiety disorder.

Meanwhile, the Committee has welcomed a new member. As of February 2014, Dimitrios Kouvelas replaced Aikaterini Moraiti as the new CHMP member for Greece.