Novartis on point in EU for asthma triple as CHMP backs Enerzair

Novartis has moved a step closer to EU approval of its three-drug asthma therapy Enerzair Breezhaler, and now looks set to beat a rival therapy from GlaxoSmithKline to market.

Enerzair (formerly QVM149) consists of long-acting beta agonist (LABA) indacaterol, long-acting muscarinic antagonist (LAMA) glycopyrronium, and inhaled corticosteroid (ICS) mometasone furoate, and is a close rival to GSK’s Trelegy triple therapy.

It has been recommended for approval by the EMA’s human medicines committee – the CHMP – as a once-daily maintenance treatment for patients whose asthma can’t be controlled with two-drug LABA/ICS drugs, which are the standard therapy for asthma in Europe.

If approved – which typically occurs within a few weeks of a positive opinion from the CHMP – it will also be the first asthma drug that can be prescribed with a digital sensor and app that helps patients take each inhaler dose effectively.

The optional sensor attaches to the base of the Breezhaler device and collects data on the use of the inhaler, sending data remotely to an app on a smartphone or similar device.

Trelegy (fluticasone furoate/umeclidinium/vilanterol) – another LABA/LAMA/ICS combination – is approved for chronic obstructive pulmonary disease (COPD) but was only filed for approval as an asthma therapy in Europe in February, so looks set to be several months behind Novartis’ drug.

Novartis says that around a third of patients with asthma have symptoms that can’t be controlled using LABA/ICS dual therapy such as GSK’s older drug Seretide – which dominated the market for years before losing patent protection.

Uncontrolled asthma is defined as having one or more breakthrough asthma attacks despite therapy in the previous year.

Last month, the CHMP also recommended approval of Novartis’ two-drug combination Atectura Breezhaler (indacaterol/mometasone furoate) as a maintenance treatment of asthma in patients whose asthma is controlled with ICS and inhaled short-acting beta agonists.

The approval recommendation is based on the IRIDIUM trial, which showed clinically meaningful improvements in lung function and reduction of exacerbations compared to two-drug treatment with Atectura.

Enerzair also has regulatory filings on the go in multiple countries, including Switzerland, Japan and Canada, but so far it hasn’t been approved for marketing anywhere in the world.

Under a respiratory drug agreement dating back more than a decade, Japan’s Sosei and its UK subsidiary Heptares will receive a $5 million payment from Novartis, and Vectura will also receive the same amount.