Advisors to the US Food and Drug Administration are backing approval of GlaxoSmithKline/Theravance’s BREO Ellipta inhaler for the treatment of asthma in adults, but not for children aged 12 to 17 years old.
At a joint meeting the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16 to four in support of the inhaler’s safety and efficacy as a once-daily treatment for adults with asthma.
But they voted against approval for this indication in 12-17 year olds (2 for, 18 against), concluding that efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and that safety (1 for, 19 against) has not been adequately shown.
Darrell Baker, Head of GSK’s Global Respiratory Franchise, said the firm “will continue to work closely with the FDA while it considers the Committee’s recommendations and our aim is to answer any outstanding questions to enable them to make a fully informed decision”
Breo Ellipta is already on the US market for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
A final decision on the proposed asthma indication is expected from the FDA on April 30.