Novartis NVS announced full results from the phase IIIb study, ARGON, on Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) in patients with asthma not adequately controlled on current inhaled therapies.
The results showed that treatment with once-daily Enerzair Breezhaler met the primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life of people with uncontrolled asthma.
The study evaluated IND/GLY/MF, a once-daily, fixed-dose combination of a long-acting beta2-agonist (LABA), a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid (ICS) in high- (150/50/160 µg) and medium- (150/50/80 µg) doses, delivered via the Breezhaler versus a free combination of twice-daily high-dose Sal/Flu (50/500μg) plus once-daily Tio (5 μg).
The full results were published online in Respiratory Medicine.
Additionally, among secondary analyses, improvements in lung function, asthma control and health status, and a reduction in moderate exacerbations were observed with once-daily high-dose IND/GLY/MF compared to a free combination of high-dose Sal/Flu plus Tio.
We note that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on IND/GLY/MF. Regulatory reviews are currently underway in multiple countries, including Switzerland and Japan.
A potential approval will make once-daily IND/GLY/MF the first LABA/LAMA/ICS fixed-dose combination approved for patients suffering from uncontrolled asthma with LABA/ICS treatment and could provide an effective and convenient alternative to the current standard-of-care regimen.
Earlier, the CHMP also recommended the approval of Atectura Breezhaler (IND/MF) as a maintenance treatment of asthma not adequately controlled with inhaled corticosteroids and inhaled short-acting beta-agonists for adults and adolescents 12 years of age and older.
Approval of these therapies should boost Novartis’ respiratory franchise, which has Xolair and the Ultibro Group, which consists of inhaled COPD therapies — UltibroBreezhaler, SeebriBreezhaler and OnbrezBreezhaler. The company has a collaboration agreement with Roche RHHBY for Xolair.
The stock has lost 10.1% in the year so far compared with the industry’s decline of 1.7%.
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, strong uptake is expected from Beovu as it is the first FDA-approved anti-VEGF to offer greater fluid resolution as compared to Regeneron REGN and Bayer’s BAYRY market-leading drug, Eylea.
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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