This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

BREO™ ELLIPTA™ Gains US Approval For The Treatment Of COPD

LONDON and SOUTH SAN FRANCISCO, Calif., May 10, 2013 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO™ ELLIPTA™ as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.  It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta 2 agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg).

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, "This approval means that we can now realise our plan to bring BREO ELLIPTA to appropriate COPD patients in the US.  We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episodes.  BREO ELLIPTA will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation."

"The FDA approval of BREO ELLIPTA brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States," said Rick E Winningham, Chief Executive Officer of Theravance. "After more than a decade of joint respiratory research and development, the approval is a very important milestone for Theravance and GSK."

Following this approval by the FDA, it is anticipated that BREO ELLIPTA will be available in the US during the third quarter of 2013.  Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of BREO ELLIPTA. 

The data submitted to the FDA to support the regulatory review of FF/VI included data from a comprehensive programme of non-clinical studies, 52 clinical pharmacology studies in 1,406 patients, and 11 clinical studies in 7,851 patients with COPD.  There were four primary COPD studies: two 6-month lung-function studies and two 1-year replicate exacerbation studies.

1 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,001.22 -38.27 -0.22%
S&P 500 1,988.40 -3.97 -0.20%
NASDAQ 4,538.5510 +6.4470 0.14%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs