GSK And Theravance Withdraw Japan NDA for Relvar COPD Indication

12 Jul 2013

GlaxoSmithKline PLC and Theravance announced July 12 the withdrawal of a new drug application in Japan for a chronic obstructive pulmonary disease indication of Relvar/Ellipta (fluticasone furoate/vilanterol), but is preparing a resubmission.

GlaxoSmithKline PLC and Innoviva Inc. announced July 12 the withdrawal of a new drug application in Japan for a chronic obstructive pulmonary disease indication of Relvar/Ellipta (fluticasone furoate/vilanterol), but is preparing a resubmission.The firms withdrew the NDA after discussions with PMDA (Pharmaceuticals Medical Devices Agency), GSK told PharmAsia News. The NDA used data from six studies, two of which included Japanese-specific efficacy data. The company concluded the two trials “were not sufficient to demonstrate statistical difference concerning additional efficacy of fluticasone furoate to vilanterol.

A PMDA review of the combination product is ongoing for asthma, and the drug is approved in the U.S. for...