Glaxo Accelerates Regulatory Plan for Triple Combo Treatment for COPD

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GlaxoSmithKline PLC (London) moved to consolidate its lead in a new class of three-in-one inhaled lung drugs on Thursday with plans to file its product for U.S. approval by the end of 2016, rather than the first half of 2018 as previously expected.

Britain’s biggest drugmaker is vying with rivals including AstraZeneca PLC (London) and Novartis AG (Basel CHE) to develop so-called “closed triple” therapies, offering a single inhaler for patients with chronic obstructive pulmonary disease (COPD).

The idea is to use three different mechanisms of action to help open the airways of patients with more severe disease, rather than just two used at present. Pharmaceutical companies see such inhalers as a significant new opportunity in a market facing competition from cheap generics, although there is debate as to how doctors would decide when to step up to or step down from triple therapy.

GSK said it had brought forward its plan to file a New Drug Application (NDA) in the United States following discussions with the Food and Drug Administration. The company, which is market leader in respiratory medicine, was already planning to submit the product for approval in Europe by the end of 2016, but winning U.S. approval is viewed by analysts as a potentially higher hurdle.

GSK’s once-daily drug is being developed with Innoviva Inc. (South San Francisco) and it combines fluticasone, umeclidinium and vilanterol in a single inhaler. The U.S. drug filing will include clinical trials data now in hand from the closed triple combination therapy development program, as well as data from studies with the component drugs, given either alone or in combination.

GSK is suffering from declining sales of its aging lung treatment Advair, which already faces generic competition in Europe and could see their arrival in the United States next year. Nonetheless, it predicts its respiratory medicine business will grow this year, driven by several new drugs. Glaxo closed the week up 6.50 pence at 1,459 pence in London.

Monday, June 6, 2016 / Vol. 24 / No. 22