The Japanese Ministry of Health, Labour and Welfare has approved two Novartis DPIs — Enerzair Breezhaler glycopyrronium / indacaterol/ mometasone furoate and Atectura indacaterol / mometasone furoate — for the treatment of asthma, the company said. The two DPIs were part of a batch of five Novartis drugs approved simultaneously by the MHLW. Sosei Heptares, which licensed glycopyrronium to Novartis in 2005, separately announced that the approval of Enerzair means that it is due a milestone payment from Novartis.
In Europe, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Atectura Breezhaler and a duplicate product, Bemrist Breezhaler, in March 2020 and recommended approval of Enerzair Breezhaler in April 2020.
Novartis Pharma Representative Director and President Kazunari Tsunaba said, “The simultaneous approval of five new products is remarkable for Japan and our industry. We are pleased to see that our innovative products gain the support from leading regulatory bodies. All five medicines are truly novel and transformative treatments and therefore mark an important milestone in our mission to reimagine medicine. I would like to thank our Japanese and global colleagues for all their dedication to make this unprecedented milestone happen.“
Sosei Heptares President and CEO Shinichi Tamura commented, “I would like to congratulate Novartis for achieving this important milestone with Enerzair. The addition of this new product and the new digital device combining a sensor with the Breezhaler inhaler provides a new option for the treatment and long-term management of under-controlled asthma. We look forward to the final decision by the European Commission in the near future 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.
