GSK and Theravance announce regulatory submissions for FF/VI in the US and Europe

Top Quote Relvar™ and Breo™ proposed as brand names for FF/VI in EU and US; new dry powder inhaler proposed to be named Ellipta™ End Quote
  • (1888PressRelease) July 13, 2012 - GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine fluticasone furoate “FF”/vilanterol “VI” (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a regulatory application for asthma in the European Union.

    European Submission:

    A Marketing Authorisation Application (MAA) for FF/VI, with the proposed brand name Relvar™, administered by a new dry powder inhaler called Ellipta™, has been submitted to the European Medicines Agency (EMA) for the following indications:

    Asthma (100/25mcg and 200/25mcg): The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.

    COPD (100/25mcg): The symptomatic treatment of patients with COPD with a FEV1

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