Novartis (NVS) Releases Positive Data on Enerzair Breezhaler

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Novartis NVS announced positive data on asthma treatment Enerzair Breezhaler from a post hoc analysis in the phase III IRIDIUM study.

The data was presented virtually at the European Respiratory Society (ERS) International Congress 2020.

Results showed that the high-dose, once-daily Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) significantly reduced the annualized rate of moderate-to-severe asthma exacerbations by 21% and severe exacerbations by 31% in asthma patients not adequately controlled by inhaled therapies compared to the medium-dose (150/50/80 μg) of more than 52 weeks.

The outcomes also showed that the high-dose Enerzair Breezhaler lowered the annualized rate of all exacerbations (mild, moderate and severe) by 14% compared to a medium dose. However, this finding was not statistically significant.

Moving on, the study data demonstrated that the safety profile of high-dose Enerzair Breezhaler was in line with the previous studies in the phase III/IIIb PLATINUM clinical development program.

The analysis supports the potential of high-dose IND/GLY/MF as an effective step-up treatment option to further mitigate asthma exacerbations in patients with uncontrolled asthma.

We note that in July, the European Commission (EC) approved Enerzair Breezhaler 150/50/160 μg once-daily as a maintenance treatment of asthma in adult patients not adequately controlled by a maintenance combination of a long-acting beta2-agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS).

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

The stock has lost 8.4% in the year so far compared with the industry’s decline of 0.5%.

After implementing a series of restructuring moves, Novartis looks to strengthen its core pharma business. Solid performance of its key drugs Cosentyx and Entresto and contributions from its gene therapy Zolgensma boosted its portfolio of late.

Cosentyx maintains a positive momentum for the company on recent label expansions despite stiff competition from AbbVie’s ABBV Humira and Johnson & Johnson’s JNJ Tremfya. New launches like Piqray and Beovu should further boost the company’s performance in the upcoming quarters.

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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