Market Overview

GSK and Theravance Announce Regulatory Submissions for FF/VI in the US and Europe


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.

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:

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.

A New Drug Application (NDA) for FF/VI, with the proposed brand name Breo™, administered by the Ellipta™ inhaler, has been submitted to the US Food and Drug Administration (FDA), for the following indication:

Posted-In: News FDA


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