GSK Files For Triple Combination Therapy FF/UMEC/VI For Patients With COPD

(RTTNews) - GlaxoSmithKline PLC (GSK.L, GSK) announced Monday the filing of a regulatory submission with the US Food and Drug Administration for once-daily closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol for patients with chronic obstructive pulmonary disease or COPD.

The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2-adrenergic agonist, delivered once-daily in GSK's Ellipta dry powder inhaler.

This follows the announcement earlier this year of plans to bring forward the timing of the US filing from the first half of 2018. Under the agreement with GSK, Innoviva, Inc. (INVA) is eligible to receive associated royalty revenues from RELVAR/BREO ELLIPTA, ANORO ELLIPTAand, if approved and commercialized, VI monotherapy, as well.

In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance Biopharma, Inc., including the closed triple combination therapy for COPD. For more information,

The company noted that the US regulatory submission of the closed triple therapy comprises a New Drug Application for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema.

A regulatory filing in the EU is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.