GlaxoSmithKline PLC (GSK) filed a regulatory submission with the U.S. Food And Drug Administration (FDA) for its new three-in-one inhaled lung therapy.

The FDA submission allows GlaxoSmithKline to take the lead against competitors like AstraZeneca PLC (AZN) and Novartis (NVS) which are also developing “triple” therapies that allow a single inhaler to treat patients with chronic obstructive pulmonary disease (COPD).

The novel triple therapy mechanism facilitates three different modes of action in the single inhaler, which helps open air passages in COPD patients. The product is being developed in partnership with Nasdaq-listed Innoviva Inc. (INVA), and combines fluticasone, umeclidinium and vilanterol drugs.

The product fares better and is more efficient than the dual therapy inhalers currently being used.

First Mover Advantage

The British drug maker is struggling with dwindling sales of its older dual therapy inhaler called Advair. Timely approval leading to marketing permission of the triple therapy inhaler will not only help GlaxoSmithKline make up for lost revenues, but it will give it a competitive edge in launching the new product.

GlaxoSmithKline expects to be the first to hit the market in 2017, provided FDA approval is received in time.

The company also plans to file for similar approval in the European Union in the coming weeks. Submissions for approvals in other nations is expected to begin next year.

COPD is a disease of the lungs that includes chronic bronchitis and emphysema, and is caused by inhaling pollutants, dust, smoke, and chemical fumes. The disease affects around 330 million people across the globe. (For more, see Brexit: GlaxoSmithKline Invests $361M in the UK.)

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