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FDA Should Not Rush to Approve Asthma Treatment, Public Citizen Tells Advisory Committee

March 19, 2015

FDA Should Not Rush to Approve Asthma Treatment, Public Citizen Tells Advisory Committee

Breo Ellipta Combination Therapy May Be Dangerous in Adolescents; Little Is Known About Safety in Adults

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should not approve the combination therapy fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma, because it may be dangerous in adolescents and little is known about its safety in adults, Public Citizen said today in testimony to the FDA’s Pulmonary and Allergy Diseases Advisory Committee.

Approximately 37 million Americans have asthma. Breo Ellipta is the latest in a long line of combination therapies developed to treat the disease that consist of an inhaled corticosteroid (ICS) and a medicine known as a long-acting beta agonist (LABA) that opens up constricted airways. Of the two components of Breo Ellipta, only fluticasone furoate (Arnuity Ellipta) is currently approved for asthma.

For more than 20 years, multiple studies have shown that giving asthma patients a LABA-containing medicine increases the risk of asthma-related hospitalizations and deaths. But there was uncertainty as to whether taking ICS lessened or eliminated the LABA’s risks. For this reason, in 2011, the FDA required the makers of all LABA-containing asthma medications to conduct large post-market studies to find out for sure whether combination LABA/ICS products were too dangerous for asthma patients. The trial results are expected in 2017.

Requiring a similarly large study of Breo Ellipta prior to approval, rather than after it is on the market, would avoid the possibility of once again exposing patients to a potentially dangerous medication while waiting for the results of a post-market study, which likely would take at least five years to complete.

The only trials conducted on Breo Ellipta to date were far smaller than those underway for all other LABA-containing asthma medications and were not designed to look for the most dangerous side effects: asthma-related hospitalization, intubation (being placed on a breathing machine) and death. Furthermore, one of the trials found that Breo Ellipta may increase the risk of severe asthma attacks in adolescent patients.

“Breo Ellipta offers no unique advantages over currently available LABA asthma therapies and has not undergone a large enough clinical trial to ensure that it does not worsen asthma outcomes, the condition it is supposed to treat,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “There is no reason to approve a ‘me-too’ medication before such a trial sheds more light on its potentially life-threatening risks.”

Read today’s testimony.