GlaxoSmithKline And Innoviva Plan To File A NDA For Triple Combination Therapy

GlaxoSmithKline plc GSK and Innoviva, Inc. INVA revealed that it plans to file a NDA for the once-daily closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; a combination inhaled corticosteroid, longacting muscarinic antagonist, long-acting beta agonist) for patients with chronic obstructive pulmonary disease (COPD). The move comes on the heels of the two companies having discussions with the US Food and Drug Administration (FDA). According to GSK and Innoviva, the US regulatory submission was now anticipated by the end of the current year, rather than the first half of the year2018, as expected earlier. The two companies stated that the NDA for the closed triple combination therapy would consist of data currently in hand from the closed triple combination therapy development program, and data from trials with FF, UMEC and VI either alone or in combination. The companies indicated that it would continue to expect an EU regulatory submission of the closed triple combination therapy for COPD before the current year ends. Glaxo and Innoviva said that the closed triple therapy was a combination of three molecules: fluticasone furoate (FF), an inhaled corticosteroid (ICS), umeclidinium (UMEC), an anti-cholinergic, also known as a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA) delivered once-daily in GSK's Ellipta dry powder inhaler. While GSK shares traded 0.14 percent higher, Innoviva stock traded 2.58 percent higher on Thursday.