Eight new meds backed for approval at April EMA/CHMP meeting

Recommendations were given for marketing authorizations of four novel drugs and four biosimilars or hybrid medicines following the April 28-30 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The recommendations will be now be reviewed by the European Commission, with a decision likely in the next two/three months.

The Committee recommended granting a marketing authorization for Swiss pharma giant Novartis’ (NOVN: VX) Enerzair Breezhaler, the first triple combination therapy for the treatment of asthma which includes an optional smart electronic sensor. Enerzair Breezhaler consists of a fixed dose combination of three active substances (indacaterol/glycopyrronium/mometasone) in capsules, to be administered using an inhaler.

The CHMP also adopted a positive opinion for Novartis’ Zimbus Breezhaler (indacaterol/glycopyrronium/mometasone) which is a duplicate of Enerzair Breezhaler for the treatment of asthma.