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Novartis' Phase IIIb Enerzair Breezhaler Trial Meets Primary Endpoint In Uncontrolled Asthma

Swiss drug major Novartis (NVS) announced Friday that its Phase IIIb ARGON study met primary endpoint in a comparison of Enerzair Breezhaler (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma.

The results show that once-daily treatment with single inhaler, high- and medium-dose Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate or IND/GLY/MF) demonstrated non-inferiority to a free combination of twice-daily, high-dose salmeterol xinafoate/fluticasone propionate or Sal/Flu plus once-daily tiotropium or Tio.

Among secondary analyses, the company observed improvements in lung function, asthma control, health status, and a reduction in moderate exacerbations in the trial.

IND/GLY/MF recently received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP and is currently under regulatory review in multiple countries.

If approved, once-daily IND/GLY/MF will be the first LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS treatment and could provide an effective and convenient alternative to the current standard-of-care regimen.

The full results from the Phase IIIb ARGON study were published online in Respiratory Medicine.

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