GSK, Innoviva File COPD NDA Early to FDA

Nov 21, 2016

GlaxoSmithKline and Innoviva Inc. filed a regulatory submission with the U.S. FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement earlier this year of plans to bring forward the timing of the U.S. filing from the first half of 2018.

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

The U.S. 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. It is based on data from the closed triple combination therapy development program, as well as data from studies with FF, UMEC and VI either alone or in combination.

Dave Allen, Head of Respiratory R&D, said, “...This first regulatory submission of our closed triple therapy brings us a step closer to providing a once-daily treatment in a single Ellipta inhaler as an alternative option for those patients who require multiple therapies.”

Mike Aguiar, CEO of Innoviva Inc., added “We are delighted that the U.S. submission has been achieved some 18 months earlier than planned. If approved, FF/UMEC/VI as a once daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients.”

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.

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