FDA Panel Backs GlaxoSmithKline, Theravance's Breo for Adults, Not Kids

Published: Mar 23, 2015

FDA Panel Backs GlaxoSmithKline, Theravance's Breo for Adults, Not Kids
March 20, 2015
By Alex Keown, BioSpace.com Breaking News Staff

A U.S. Food and Drug Administration (FDA) advisory panel voted that Breo Ellipta, GlaxoSmithKline ’s drug to treat chronic breathing issues is safe for adults with asthma to use, but not for adolescents.

The Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-4 that Breo Ellipta, which was licensed from Theravance, Inc. in 2002, should be approved for once daily treatment of asthma in adults 18 years and older, Reuters reported Friday. The panel voted 19-1 that the data did not support approval for use in children aged 12 to 17.

Breo Ellipta consists of a corticosteroid, which reduces inflammation, and vilanterol, a long-acting beta-agonist (LABA), which is designed to open the airways. The medication was approved by the FDA in May 2013 for use as a once-daily prescription medication for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It has not yet been approved as a treatment for asthma, something GlaxoSmithKline hopes will come at the end of next month. The company filed a new drug application to use Breo Ellipta as an asthma treatment in June 2014. The FDA is expected to rule on whether to approve the drug by the end of April.

Because the LABA class of drugs has been linked with asthma-related deaths in the past, the FDA panel recommended that a large LABA safety trial should be required in adults and in youths 12 to 17 year of age, similar to ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments, including Glaxo's Advair, AstraZeneca PLC 's Symbicort and Merck & Co. 's Dulera and Foradil, in both adolescents and adults, GlaxoSmithKline said following the panel’s ruling. LABA drugs already come with warning labels noting the risks of taking such a medication.

According to the FDA, one panel member indicated that he intended to vote against the drug, however a vote cannot be changed once read into the official FDA records.

GlaxoSmithKline said it will continue to work with the FDA while it considers the committee’s recommendations. The FDA is not obliged to follow the advice of its advisory panels but typically does so, Reuters reported reported.

Asthma, a chronic lung disease that inflames and narrows the airways, affects approximately 26 million people in the United States, including 7 million children, according to the National Institutes of Health (NIH).

Based on the FDA panel ruling, an analyst told Reuters he believed sales of Breo Ellipta could reach $750 million by 2020.

GlaxoSmithKline’s stock was trading slightly up this morning after a slight drop at closing on Thursday.

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