20th Mar 2015 06:24
LONDON (Alliance News) - An asthma treatment co-developed by GlaxoSmithKline PLC 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 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.
Copyright RTT News/dpa-AFX
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