FDA panel backs Glaxo inhaler for adults, not adolescents

March 19, 2015 byMatthew Perrone

Government health advisers say a once-a-day respiratory inhaler from GlaxoSmithKline appears safe and effective for adults with asthma, but not for adolescents.

The Food and Drug Administration panel of experts voted 18-2 that evidence submitted by the British drugmaker for its Breo Ellipta inhaler does not support its use in ages 12 to 17. That followed a positive vote of 16-4 supporting the 's use in asthma patients 18 and up.

The FDA is not required to follow the recommendations of its experts, though it often does.

Breo Ellipta is already approved in the U.S. for a type of , but Glaxo is hoping to expand the drug's use to the much larger patient population of roughly 37 million Americans with asthma.

Like several other respiratory drugs, Breo Ellipta combines two inhalable drug ingredients: a steroid and a long-acting beta agonist, or LABA for short. LABA-containing drugs have been subject to FDA warnings for several years and their current labeling warns doctors that they should only be prescribed to asthma patients who can't control their condition with other medications—and then only for the shortest time possible. While LABA drugs can be helpful in preventing day-to-day symptoms for some asthma patients, their use can also mask inflammation that builds up in the lung's airways. That means patients may not realize a serious asthma attack is brewing until they're gasping for air.

In 2010, FDA required manufacturers of LABA-steroid combination drugs, including Glaxo, to conduct large safety studies measuring rates of hospitalization and death. Results of those studies aren't expected until 2017.

The FDA's panel voted Thursday that Glaxo should be required to conduct a separate large safety study of Breo Ellipta in both adults and adolescents.

LABA drugs do not carry the same risks for patients with other respiratory diseases, and Breo Ellipta was previously approved by the FDA for chronic obstructive pulmonary disorder, or COPD, which can cause chronic bronchitis and emphysema.

Breo Ellipta is one of several drugs Glaxo is counting on to replace deteriorating sales of its best-selling product, Advair, which uses an older combination of LABA and steroid drugs. Sales of Advair, which is approved for both asthma and COPD, fell nearly 20 percent last year to $6.9 billion, according to sales tracker GlobalData. U.S. sales of Advair and other have been squeezed by pharmacy benefit managers, who are increasingly seeking steeper discounts from drugmakers in return for placing their products on formulary lists of preferred medications. Additionally, Advair faces generic competition in some European countries.

London-based Glaxo pays royalties on Breo Ellipta to co-developer Theravance Inc., which is based in San Francisco.

Glaxo said in a statement: "We will continue to work closely with the FDA while it considers the committee's recommendations and our aim is to answer any outstanding questions."

Explore further: FDA approves once-a-day inhaler from Glaxo

Related Stories

FDA approves once-a-day inhaler from Glaxo

May 10, 2013
The Food and Drug Administration says it has approved a new once-a-day inhaler drug from GlaxoSmithKline for patients with chronic lung disease.

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.

Anoro ellipta approved for COPD

December 18, 2013
(HealthDay)—A new inhaled drug to treat a serious lung condition called chronic obstructive pulmonary disease (COPD) has been approved by the U.S. Food and Drug Administration.

Elan enters $1B royalty deal with Theravance

May 13, 2013
Irish drugmaker Elan Corp. PLC plans to pay $1 billion for the right to future royalties from four respiratory treatments being developed by Theravance Inc. and GlaxoSmithKline.

FDA approves Boehringer's once-a-day inhaler drug

July 31, 2014
(AP)—The Food and Drug Administration has approved a new long-acting inhaler drug from Boehringer Ingelheim to treat people with chronic lung disease.

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

Vaccinating against psoriasis, allergies and Alzheimer's a possibility, research shows

October 23, 2017
Research from the Universities of Dundee and Oxford has shown how combining the tetanus vaccine with a viral particle that normally affects cucumbers can be used to treat psoriasis and allergies, and may even protect against ...

Fighting opioid addiction in primary care—new study shows it's possible

October 18, 2017
For many of the 2 million Americans addicted to opioids, getting good treatment and getting off prescription painkillers or heroin may seem like a far-off dream.

With no morphine, 25 million die in pain each year: report

October 13, 2017
Every year, some 25 million people—one in ten of them children—die in serious pain that could have been alleviated with morphine at just a few cents per dose, researchers said Friday.

Study finds few restrictions on Rx opioids through Medicare

October 9, 2017
Medicare plans place few restrictions on the coverage of prescription opioids, despite federal guidelines recommending such restrictions, a new Yale study finds. The research results highlight an untapped opportunity for ...

Nocebo effect: Does a drug's high price tag cause its own side effects?

October 5, 2017
Pricey drugs may make people more vulnerable to perceiving side effects, a new study suggests—and the phenomenon is not just "in their heads."

Pre-packaged brand version of compounded medication to prevent preterm births costs 5,000 percent more

October 2, 2017
Preventing a preterm birth could cost as little as $200 or as much as $20,000, depending on which one of two medications a doctor orders, according to a new analysis from Harvard Medical School.


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.