CHMP adopts positive opinion regarding Atectura Breezhaler and Bemrist Breezhaler

At a March 27, 2020 meeting of the EMA’s Committee for Medicinal Products for Human Use (CHMP), the committee adopted a positive opinion regarding the MAAs for Novartis’s Atectura Breezhaler indacaterol/mometasone furoate and a duplicate inhaler, Bemrist Breezhaler. Both will be available in 125 mcg/260 mcg, 125 mcg/127.5 mcg and 125 mcg/62.5 mcg strengths for the treatment of asthma in patients aged 12 and older once approved.

In May 2019, Novartis announced that the Phase 3 QUARTZ study had demonstrated that QMF149 indacaterol/mometasone furoate delivered via the Breezhaler DPI produced statistically significant and clinically meaningful lung function and asthma control improvements compared to mometasone furoate alone.

At that time, Novartis said that an MAA for QMF149 had been accepted by the EMA and was under review, as was a submission for its QVM149 indacaterol/glycopyrronium/mometasone DPI.

Read the CHMP summary of the positive opinion for Atectura Breezhaler.
Read the CHMP summary of the positive opinion for Bemrist Breezhaler.