Visitors Now:
Total Visits:
Total Stories:
Profile image
By ProactiveInvestors (Reporter)
Contributor profile | More stories
Story Views

Now:
Last Hour:
Last 24 Hours:
Total:

GlaxoSmithKline and Innoviva celebrate early FDA submission of COPD treatment

Monday, November 21, 2016 2:01
% of readers think this story is Fact. Add your two cents.

(Before It's News)

Drugs giant GlaxoSmithKline plc (LON:GSK,NYSE:GSK) and its partner Innoviva Inc (NASDAQ:INVA) have filed a regulatory submission for a treatment for chronic obstructive pulmonary disease (COPD).

The new drug application submission to the US Food and Drugs Administration was made 18 months ahead of schedule.

The treatment for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema, is a once-a-day closed triple combination therapy, consisting of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI).

Dave Allen, head of Respiratory Research & Development at Glaxo, said multiple therapies in combination are often required for those patients with advanced forms of COPD.

“This first regulatory submission of our closed triple therapy brings us a step closer to providing a once-daily treatment in a single Ellipta inhaler as an alternative option for those patients who require multiple therapies,” Allen said.

Mike Aguiar, chief executive of Innoviva, said the company was delighted that the US submission had been achieved some 18 months earlier than expected.

A regulatory filing in the European Union is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.

Story by ProactiveInvestors

Report abuse

Comments

Your Comments
Question   Razz  Sad   Evil  Exclaim  Smile  Redface  Biggrin  Surprised  Eek   Confused   Cool  LOL   Mad   Twisted  Rolleyes   Wink  Idea  Arrow  Neutral  Cry   Mr. Green

Top Stories
Recent Stories

Register

Newsletter

Email this story
Email this story

If you really want to ban this commenter, please write down the reason:

If you really want to disable all recommended stories, click on OK button. After that, you will be redirect to your options page.