US panel backs inhaler drug for lung disease

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.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Tudorza pressair approved for COPD

Jul 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) ...

FDA panel unanimously backs Onyx cancer drug

Jun 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.

1990s trial gave early danger signs for asthma drugs

Nov 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

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

User comments