FDA Panel Recommends Approval Of GSK Asthma Drug For Adults But Not Adolescents

(RTTNews) - An asthma treatment co-developed by GlaxoSmithKline and Theravance has been found safe and effective by a FDA review panel in treating adults but not adolescents.

The FDA panel voted in favor of Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as an once-daily inhaled treatment for asthma in patients aged 18 years and older by a 16-4 vote.

However, the panel voted against the asthma drug for treating patients aged between 12 and 17 years, with the panel voting 2 for and 18 against.

Breo, a fixed-dose combination of the inhaled corticosteroid FF and the long-acting beta2-agonist VI, is administered with the Ellipta dry powder inhaler device.

The panel voted on the supplemental New Drug Application (sNDA) for the drug as a once-daily inhaled treatment for asthma in patients aged 12 years and older.

The voting was conducted at a joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA.

The sNDA for Breo Ellipta in asthma was submitted to the FDA in June 2014 for two once-daily dose regimens, 100/25 mcg and 200/25 mcg. Breo Ellipta (FF/VI 100/25 mcg) was licensed by the FDA under the brand name in May 2013.

The FDA is now expected to make its final decision on approval on April 30, 2015, the Prescription Drug User Fee Act goal date, based on the opinions and data presented by the panel. However, the panel's recommendation is non-binding, and the FDA can make their own decision on the approval.

"We recognise the Advisory Committee's thoroughness in reviewing the data related to Breo Ellipta for asthma. 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 to enable them to make a fully informed decision," said Darrell Baker, SVP & Head, GSK Global Respiratory Franchise.

Asthma is a chronic lung disease that inflames and narrows the airways. About 26 million people in the USA currently have asthma. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.

GSK closed Thursday's regular trading session at $48.21, down $0.53 or 1.09% on a volume of 3.15 million shares, and THRX was flat in regular trading but plunged $1.75 or 9.74% to $16.22 in after-hours trading.