Reuters: Regulatory News: GSK, Theravance pull Relvar filing for COPD in Japan

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GSK, Theravance pull Relvar filing for COPD in Japan Jul 12th 2013, 07:18 LONDON, July 12 | Fri Jul 12, 2013 3:18am EDT LONDON, July 12 (Reuters) - GlaxoSmithKline and its smaller U.S. partner Theravance have withdrawn an application for approval to sell their new inhaled drug Relvar as a treatment for chronic lung disease in Japan. The decision follows concerns that six-month clinical data on the drug might not be strong enough to secure approval in Japan. No Japanese patients were included in two other longer 52-week studies. The partners said on Friday they had therefore decided to withdraw their Japanese application for chronic obstructive pulmonary disease (COPD). The application to use Relvar as a treatment for asthma remains under review in Japan.

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