GSK, Innoviva seek EU nod for triple combo inhaled therapy

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S.

The triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s Ellipta dry powder inhaler. The regulatory submission is backed by clinical data that includes the phase III Fulfil study, which compared once daily FF/UMEC/VI with AstraZeneca‘s (NYSE:AZN) twice daily Symbicort Turbohaler in patients with advanced COPD. The triple combo therapy demonstrated improved lung function and statistically significant reductions in exacerbations.

“Many patients with COPD are already at an advanced stage when they are diagnosed. Prescribing patterns show the importance of having a range of options available to meet the differing needs of individual patients,” GSK R&D head of respiratory therapy area unit Dave Allen said in prepared remarks. “An approval of our closed triple therapy in Europe would complement our portfolio of inhaled therapies designed for once-daily dosing in a single inhaler, offering patients a convenient, alternative option.”

“The EU filing of the closed triple combination is the latest development in our long-standing collaboration with GSK,” Innoviva CEO Mike Aguiar added. “If approved, FF/UMEC/VI as once daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients.”