FDA nod follows CHMP recommendation for first COPD triple therapy

19 September 2017
gsk-building-big

Just days after receiving a positive committee recommendation setting it up for approval in Europe, the first once-daily product that combines three active molecules in a single inhaler as a maintenance treatment for appropriate patients with chronic obstructive pulmonary disease (COPD), has been given the nod by the US regulator.

UK drug major GlaxoSmithKline (LSE: GSK) and its US partner Innoviva (Nasdaq: INVA) have achieved this milestone with their combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), to be marketed under the brand name Trelegy Ellipta.

"The addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for GSK"

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical