GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta.
The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not adequately treated by a inhaled corticosteroid combined with a long-acting beta-adrenergic agonist. GSK and Innoviva hope that data from its Impact trial will support the product’s use in a broader population of COPD patients who are at risk of exacerbation.
The Impact trial, which enrolled 10,355 patients, demonstrated statistically significant reductions in the annual rate of on-treatment moderate to severe exacerbation when compared with two, once-daily dual COPD therapies from GSK’s existing portfolio.
The safety profile of Trelegy Ellipta was consistent with the known profile of the individual medicines and their combinations, the companies reported. The most common adverse events were viral upper respiratory tract infection, worsening of COPD, pneumonia and headache.
“This filing is primarily based on the Impact study, which clarifies the type of patient most likely to benefit from once-daily single inhaler triple therapy, and adds to the evidence supporting the clinical profile of Trelegy Ellipta,” Dave Allen, head of GSK’s respiratory therapy area R&D unit, said in prepared remarks.
“The submission reflects our confidence in this medicine, which we believe has the potential to be an effective treatment option for appropriate patients with COPD who require triple therapy for symptom relief and exacerbation reduction.”
“The data included in this submission build on existing evidence supporting the role of once-daily single inhaler triple therapy in the treatment of appropriate patients with COPD. If approved, updates to the Trelegy Ellipta labelling will give clinicians additional information to help guide their treatment choices,” Innoviva’s chief scientific officer & SVP, Theodore Witek Jr., added.
The three-in-one inhaler was also approved for sale in the U.S. by the FDA in September last year.
