GlaxoSmithKline plc (GSK) and biopharmaceutical company Theravance, Inc. announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of Breo Ellipta as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against).

Breo Ellipta, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate “FF” and the long acting bronchodilator (LABA) vilanterol “VI” (FF/VI).

The FDA Advisory Committee also voted that the safety of FF/VI 100/25 mcg once daily in COPD has been adequately demonstrated for the proposed indications (10 for, 3 against).

Patrick Vallance, GSK’s president of pharmaceuticals, R&D, said: “We are pleased with the outcome of today’s meeting. COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients’ lives. This positive recommendation is a crucial first step towards making Breo Ellipta available for appropriate COPD patients across the US. We look forward to a final decision from the FDA later this year.”

“After a decade of development in this programme, our collaboration with GSK is one step closer to providing an important therapeutic option to COPD patients,” said Rick E Winningham, chief executive officer of Theravance. "We are proud to collaborate with GSK on the development and potential commercialisation of treatments for COPD and other respiratory diseases. The panel’s positive recommendation of Breo Ellipta represents an important achievement in a transformative year for Theravance.”

In June 2012, a regulatory application for FF/VI was submitted in the European Union under the trade name Relvar for the treatment of patients with COPD and asthma.  In the United States, BREO Ellipta is not proposed for the relief of acute bronchospasm or for the treatment of asthma. GSK and Theravance are reviewing the strategy for a future US filing for asthma.

The FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for FF/VI is 12 May 2013.

One panel member indicated that he intended to vote no, however a vote cannot be changed once read into the official FDA record.

FF/VI, previously referred to as Relovair, is an investigational medicine and is not currently approved anywhere in the world.

Breo Ellipta is one of several late-stage assets in the GSK respiratory development portfolio, which includes LAMA/LABA (UMEC/VI, with proposed brand name Anoro Ellipta), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK’s investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab).  These investigational medicines are not currently approved anywhere in the world.

Anoro, Relvar, Breo and Ellipta are trademarks of the GlaxoSmithKline group of companies. The use of these brand names is not approved by any regulatory authorities.