1. Scrip
  2. >>Focus On Asia
  3. >>Japan

GSK And Theravance Withdraw Japan NDA for Relvar COPD Indication

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Japan

More from Focus On Asia

Battle For Obesity Market Shifts Gears in India: Will Wegovy Trump Mounjaro?

 
• By Anju Ghangurde

Novo Nordisk debuts Wegovy in India, gears for pole position in obesity. The Danish group’s leadership doesn’t appear too perturbed about the head start for Lilly’s Mounjaro or the imminent arrival of generic semaglutide next year.

Bitcoin Player Parataxis To Acquire Bridge Biotherapeutics After IPF Failure

 
• By Jung Won Shin

After the failure of its lead asset in a Phase II trial earlier this year, Korea's Bridge Biotherapeutics has accepted an acquisition offer from bitcoin group Parataxis.

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By Xu Hu

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.