At its April 2020 meeting, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Enerzair Breezhaler (QVM149) indacaterol / glycopyrronium / mometasone for the treatment of uncontrolled asthma as well as for a duplicate inhaler, Zimbus Breezhaler. Novartis partners Vectura and Sosei announced in May 2019 that Novartis had filed an MAA for QVM149.
The recommendation comes one month after CHMP recommended approval of Novartis’s Atectura Breezhaler indacaterol/mometasone furoate and a duplicate, Bemrist Breezhaler. According to Novartis, the company has submitted marketing applications for both Enerzair and Atectura in a number of countries, including Switzerland, Japan, and Canada.
If the DPI is approved, healthcare providers will be able to prescribe the DPI with a Propeller Health sensor and app that has been designed specifically for use with Enerzair Breezhaler.
Novartis Respiratory Development Unit Head Linda Armstrong said, “Today’s news is a key milestone in our journey to reimagine asthma care by bringing innovative medicines and a digital companion to patients with uncontrolled asthma. Once-daily IND/GLY/MF has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence.”
Sosei Heptares, which licensed glycopyrronium to Novartis in 2005, said that the CHMP opinion does not trigger any milestone payments; however, approval of Enerzair Breezhaler would trigger a $5 million milestone payment. Sosei would also receive royalties on net sales.
Sosei Heptares President and CEO Shinichi Tamura commented, “The recommendation for the approval of Enerzair Breezhaler is a great step towards it becoming available to the many uncontrolled asthma patients in the European Union. The extensive clinical trial program conducted by Novartis demonstrated robust efficacy and safety data with once-daily IND/GLY/MF showing significant improvements in lung function over a standard-of-care therapy If approved, this novel product would become the first LABA/LAMA/ICS combination therapy for uncontrolled asthma administered using a single inhaler with additional features in-built to support treatment adherence. We look forward to the final decision by the EC in the next two months and further updates in relation to filings in other countries over the coming year.”
Read the Novartis press release.
Read the Sosei Heptares press release.
