US panel backs inhaler drug for lung disease

April 17, 2013

A panel of U.S. respiratory experts voted Wednesday in favor of approving an experimental inhaler drug from GlaxoSmithKline and Theravance for treating chronic lung disease.

A majority of panelists voted that the Breo Ellipta inhaler is safe and effective for long-term use and to control flare ups in patients with chronic obstructive pulmonary disorder or COPD.

The FDA is not required to follow the group's recommendation, though it often does. The agency is expected to make a decision by May 12.

The lung ailment, often called smoker's cough, can cause a number of breathing problems, including and emphysema.

Breo is a combination of two respiratory drugs that can help open lung air passages and reduce swelling. The drug is designed to be used with the Ellipta inhaler device.

The British drugmaker said in a statement following the meeting: "This positive recommendation is a crucial first step toward making Breo Ellipta available for appropriate COPD patients across the U.S."

The drug is also under regulatory review in the European Union.

Glaxo, a leader in respiratory medicine, already sells the Advair, its best-selling product with more than $4 billion in sales per year. Breo Ellipta is one of several experimental respiratory drugs on which the U.K. drugmaker and Theravance are collaborating.

Trading of Theravance Inc. was halted Wednesday morning, ahead of the FDA meeting. 's U.S.-listed shares rose 95 cents to close at $50.33 in trading. The broader markets ended lower.

Explore further: Researchers question safety of mist inhalers for delivering common drug for chronic lung disease


Related Stories

FDA panel unanimously backs Onyx cancer drug

June 21, 2012

(AP) — A federal panel of cancer specialists on Wednesday unanimously recommended approval of an experimental drug from Onyx Pharmaceuticals Inc. for patients with advanced blood cancer.

Tudorza pressair approved for COPD

July 24, 2012

(HealthDay) -- The Tudorza Pressair (aclidinium bromide) inhaler has been approved by the U.S. Food and Drug Administration to treat narrowing of the lung airways associated with chronic obstructive pulmonary disease (COPD) ...

1990s trial gave early danger signs for asthma drugs

November 25, 2012

The troubled history of asthma drugs known as long-acting beta-agonists goes back to the 1990s when a large clinical trial in Great Britain of the GlaxoSmithKline drug Serevent produced disturbing results.

Recommended for you

Re-framing the placebo effect and informed consent

October 29, 2015

(Medical Xpress)—Imagine that your doctor knows from evidence-based studies that if he tells you about certain, small side-effects to a particular drug, you are significantly more likely to experience that side effect than ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.