Advisors to the US Food and Drug Administration have given the thumbs up to GlaxoSmithKline/Theravance's chronic obstructive pulmonary disease (COPD) inhaler Breo Ellipta, leaving the product just a hair's breadth away from approval for the all-important US market.
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted nine-to-four that efficacy and safety data indeed support approval of the inhaler, as a once-daily treatment for the long-term, maintenance treatment of airflow obstruction in COPD patients and also for the reduction of exacerbations in patients with a history of them.
Support for the combination respiratory therapy on the safety side was also strong, with 10-against-three voting that it had been adequately demonstrated for the proposed indications.
Patrick Vallance, GSK's President of Pharmaceuticals, R&D, said the firm is pleased with the advisory committee's decision which, he notes, is "a crucial first step towards making Breo Ellipta available for appropriate COPD patients across the US".
Breo Elipta (fluticasone furoate/vilanterol) combines an inhaled corticosteroid with a long-acting beta-agonist delivered via the new dry powder inhaler Ellipta.
The drug has been referred to as 'Super Advair', as it is the follow-up to GSK's biggest-selling drug Advair (salmeterol/fluticasone), although the data package for the new combo has left some analysts underwhelmed with concerns that efficacy data were on the weak side.
The FDA, which tends to follow the advice of its committees, is expected to make its decision by May 12.
If successful, Breo Ellipta could rake in sales of $1.3 billion by 2018, according to an average of five analysts’ estimates put together by Bloomberg.