Novartis Gets EC Approval for Enerzair Breezhaler for Asthma

Novartis NVS announced that the European Commission (EC) has approved Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]).It was granted approval as a maintenance treatment of asthma in adult patients 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 European Union (EU) for these patients. Enerzair Breezhaler can be prescribed together with a digital companion — a Propeller Health sensor and app — custom-built for the Breezhaler device. The sensor and app will provide inhalation confirmation, medication reminders and access to objective data so that better decisions can be made regarding the disease.

The EC approval is based on robust efficacy and safety data from more than3,000 patients with asthma inthe phase III IRIDIUM study, in which Enerzair Breezhaler demonstrated statistically significant improvements in lung function compared with Atectura Breezhaler (IND/MF).  The purpose of the study was to evaluate the efficacy and safety of two different doses of Enerzair Breezhaler (high: 150/50/160 μg and medium:150/50/80 μg) versus two corresponding Atectura Breezhaler doses (high: 150/320 μg and medium: 150/160 μg) in patients with uncontrolled asthma.

Asthma affects an estimated 358 million people worldwide and can cause a significant loss to health and finance if not adequately controlled.

We note that once-daily Enerzair Breezhaler has been approved in Japan and Canada. Once-daily Atectura Breezhaler has been approved in the EU as a maintenance treatment of asthma for adults and adolescents 12 years of age and older not adequately controlled with ICS and inhaled short-acting beta₂-agonists (SABA), and in Canada and Japan.

Approval of these therapies should boost Novartis’ respiratory franchise, which has Xolair and the Ultibro Group, which consists of inhaled COPD therapies — Ultibro Breezhaler, Seebri Breezhaler and Onbrez Breezhaler. The company has a collaboration agreement with Roche RHHBY for Xolair.

The stock has lost 4.4% in the year so far against the industry’s growth of 1.4%.

After having gone through a series of restructuring moves, Novartis looks to strengthen its core pharma business. Solid performance of key drugs like Cosentyx and Entresto and contributions from gene therapy, Zolgensma, have boosted performance, lately.

New launches like Piqray and Beovu should further boost the company’s performance in the upcoming quarters. In particular, Beovu is expected to offer greater fluid resolution as compared to Regeneron REGN and Bayer’s BAYRY market-leading drug, Eylea as it is the first FDA approved anti -VEGF.

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Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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