GSK, Innoviva seek expanded label for triple inhaler

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler.

The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease.

Trelegy Ellipta, which won FDA approval in September, is the first once-daily COPD therapy to combine three molecules in a single inhaler. GSK’s Ellipta dry powder inhaler delivers an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist. Right now, the product is approved for the long-term treatment of COPD in patients who are taking other medication but still need additional bronchodilation.

The Impact study found that the triple inhaler was better than dual combination therapies at lessening exacerbation rates and improving lung function, GSK reported.

“Data from GSK’s landmark Impact study provide important information on the efficacy and safety of these molecules combined in a single inhaler and the benefit they can bring to appropriate patients when delivered as a triple combination therapy,” GSK’s president of R&D, Patrick Vallance, said in prepared remarks. “We have moved swiftly to file these data with the FDA.”

“Trelegy Ellipta adds to the portfolio of Ellipta inhaled therapies, which has been developed because patients have different treatment needs,” Innoviva CEO Michael Aguiar added. “We believe the Impact data will provide clarity to physicians on how to treat patients based on their symptoms and risk profile and that Trelegy Ellipta will play an important role in treating patients who remain symptomatic and at risk of an exacerbation despite current therapy.”

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