The European Medicines Agency (EMA) has accepted Sosei Heptares’ filing for QVM149, a potential new inhaled combination therapy for asthma.
Novartis is responsible for the development and commercialisation of QVM149, and will be paying the $2.5 million to Sosei, triggered by the MAA filing, which was previously planned for the fourth quarter of 2019.
The drug is an investigational, once-daily, fixed dose triple therapy asthma treatment consisting of indacaterol acetate, glycopyrronium bromide and mometasone furoate delivered with the dose-confirming Breezhaler inhalation device.
Shinichi Tamura, chairman, president and CEO of Sosei Heptares, said: “The acceptance of the MAA submission for QVM149 is an important milestone in the development of this novel, once daily, inhaled combination therapy for asthma patients.
More than one-third of asthma patients have uncontrolled disease despite the availability of multiple therapies. With the filing of the MAA for approval in Europe, we are greatly looking forward to see QVM149 become available to patients and improve the lives of those with uncontrolled asthma.”
The company recently announced positive data from two Phase II clinical studies, in which QVM149 was shown to be superior to the comparators.
