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FDA OKs review of GSK/Theravance lung drug

Daily News | September 27, 2012

Selina McKee

FDA OKs review of GSK/Theravance lung drug

US regulators have agreed to review GlaxoSmithKline and Theravance's application to market a new medicine for the treatment of chronic obstructive pulmonary disease (COPD), widely viewed to be a follow-on to GSK's blockbuster Advair/Seretide.

The companies have submitted a New Drug Application in the US for the once-daily investigational drug fluticasone furoate/vilanterol (FF/VI; previously known as Relovair), which combines an inhaled corticosteroid with a long-acting beta-agonist administered via a new dry powder inhaler called Ellipta.

The US Food and Drug Administration is expected to announce its decision by May 12 next year and, if successful, the companies are planning on marketing the product under the brandname Breo.

The drug is also currently under review in Europe for COPD and asthma, while an application has this week also been submitted to regulatory authorities in Japan for both these indications. 

In these territories, the firms intend to sell the drug as Relvar, subject to regulatory approval.

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