GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said yesterday that they filed a supplemental New Drug Application with the FDA, seeking an additional indication for GSK’s Trelegy Ellipta inhaler for the treatment of asthma in adults.
The once-daily, single-inhaler triple-therapy device received FDA approval for the treatment of chronic obstructive pulmonary disease in September 2017. Trelegy Ellipta has not yet been indicated for relief of acute bronchospasm or for the treatment of asthma.
The inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma.
After a pivotal Phase III clinical trial conducted in 15 countries with 2,436 adult patients who had uncontrolled asthma reported positive headline results in May, London-based GSK and Innoviva went ahead in search of the additional indication for adults with asthma.
The randomized, double-blinded and active-controlled trial met its primary endpoint, but failed to meet a secondary endpoint of annual rate of moderate/severe asthma exacerbations. However, the trial displayed statistically significant lung function improvements for both Trelegy Ellipta dosage formulations compared with the corresponding Relvar/Breo treatments.
“Around 30% of asthma patients adherent to ICS/LABA combination therapy still experience symptoms,” GSK SVP of development Christopher Corsico said in prepared remarks. “This filing is an important step towards giving asthma patients an additional treatment option. If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.”
Shares of GSK were up 0.7% at $41.48 per share, while shares of INVA were up 2.3% at $10.52 per share in mid-afternoon trading today.