An FDA review panel has found that an asthma treatment co-developed by GlaxoSmithKline and Theravance is safe and effective in treating adults, but not adolescents.

Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) has received FDA panel's support to be used as once-daily inhaled treatment for the asthma patients aged 18 years and older, by a 16-4 vote.

But at the same time, the panel has voted against the use of asthma drug for treating patients aged between 12 and 17 years, with the panel voting 2 in favor and 18 against.

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

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

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

In June 2014, the FDA received the submission of the sNDA for Breo Ellipta in asthma, for two once-daily dose regimens, 100/25 mcg and 200/25 mcg. The FDA gave license to Breo Ellipta (FF/VI 100/25 mcg) under the brand name in May 2013.

It is expected that the FDA will make its final decision regarding the approval, on April 30, 2015, the Prescription Drug User Fee Act goal date. It will be based on the opinions and data presented by the panel.

But, the panel's recommendation is non-binding, and thus there are chances that the FDA can make their own decision on the approval.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, "We recognize 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".

He added that their aim is to stay ready to answer any kind of question to enable the FDA make a fully informed decision.