Novartis banks EC approval for Enerzair Breezhaler

The European Commission (EC) has approved Novartis' Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate) for uncontrolled asthma.

More specifically, the drug has been cleared as a maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.

Once-daily Enerzair Breezhaler is the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination available in the EU for these patients, Novartis noted.

It also includes an optional digital companion with sensor and app that confirms inhalation of the medicine, medication reminders and access to 'objective data' to better support therapeutic decisions.

“Novartis is working to reimagine medicine for people with uncontrolled asthma, who find it a challenge to achieve effective symptom and exacerbation control,” said Rod Wooten, head of Global Marketing, Novartis Pharmaceuticals.

“The approval of Enerzair Breezhaler with sensor and app in the EU is an example of our commitment to utilise data and digital offerings to make asthma control an achievable goal for patients and physicians.”

“Today, over 45% of asthma patients at GINA Steps 4 and 5 remain uncontrolled, demonstrating the need for new treatments, delivery approaches and patient support to ensure that medication is taken correctly and treatment goals are reached,” added Professor David Price, chair of Primary Care Respiratory Medicine, University of Aberdeen.

“Once-daily Enerzair Breezhaler plus a digital companion could help to facilitate greater collaborative disease management between physicians and patients in the EU whose asthma remains uncontrolled, despite LABA/ICS treatment.”

The approval rides on the back for data from over 3,000 asthma patients in the Phase III IRIDIUM study, in which once-daily Enerzair Breezhaler was shown to be superior to once-daily Atectura Breezhaler in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment.

Enerzair Breezhaler utilises Vectura’s formulation IP. As such, European regulatory approval of the product has triggered a $5.0 million milestone to Vectura from Novartis, following on from $1.25 million from its Japanese approval late last month.