GlaxoSmithKline plc (GSK) and Theravance, Inc. announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States (US) Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as a once-daily inhaled treatment for asthma in patients aged 12 years and older.
The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against).
The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population.
The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments.
FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on 30 April 2015 (the Prescription Drug User Fee Act goal date).
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 sNDA for Breo Elliptain asthma was submitted to the FDA in June 2014 for two once-daily dose regimens, 100/25 mcg and 200/25 mcg.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: “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.”
Michael W. Aguiar, president and chief executive officer of Theravance, Inc., said: "We remain committed to the ongoing review process and will be fully cooperating with the FDA to ensure it has all it needs to consider the sNDA for Breo Elliptain asthma. We look forward to the final outcome expected in April.”
Breo Ellipta (FF/VI 100/25 mcg) was licensed by the US Food and Drug Administration under the brand name Breo Ellipta in May 2013 as a prescription medication 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. Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of asthma in the US.
Theravance, Inc. – is focused on maximizing the potential value of the respiratory assets partnered with Glaxo Group Limited (GSK), including Relvar/Breo Ellipta and Anoro Ellipta, with the intention of providing capital returns to stockholders.