GlaxoSmithKline plc and Theravance, Inc., a biopharmaceutical company, have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/vilanterol (FF/VI) under the proposed brand name Relvar Ellipta.

Relvar Ellipta for asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists

Relvar Ellipta for COPD: the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy

Relvar is a combination of the inhaled corticosteroid (ICS) fluticasone furoate “FF” and the long-acting beta2-agonist (LABA) vilanterol “VI”.  Two strengths of FF/VI are proposed for asthma (92/22 mcg and 184/22 mcg) and one strength is proposed for COPD (92/22 mcg). All strengths will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI).


Patrick Vallance, GSK’s president of Pharmaceuticals R&D, said: “Asthma and COPD are two of the most common respiratory conditions and affect millions of patients across Europe. GSK has been researching and developing these molecules as a potential new combination treatment for over ten years and today’s opinion brings it one step closer to patients.  What is particularly exciting is that we have achieved the first of what we hope in the future could be many positive regulatory outcomes supporting the potential use of FF/VI in appropriate patients with asthma.   We eagerly await the final decision of the European Commission in the near future.”

“This is another key milestone in over a decade of joint respiratory research and development between Theravance and GSK,” said Rick E Winningham, chief executive officer of Theravance.

"We look forward to a number of important events during the remainder of 2013, including a final decision in Europe for FF/VI and the launch in the US for the treatment of COPD.”

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation. A final decision by the European Commission is anticipated during the fourth quarter of 2013.

As part of its assessment, the EMA reviewed results of 11 clinical studies in 7,851 patients with COPD and 16 studies in 9,326 patients with asthma.

FF/VI 100/25 mcg was approved by the US Food and Drug Administration for use in patients with COPD in May 2013 under the trade name Breo Ellipta. It was also approved for the treatment of COPD by Health Canada in July 2013 under the same trade name.

In Europe, the FF/VI doses of 92/22 mcg and 184/22 mcg are specified as the delivered doses (emitted from the inhaler). The lower strength is equivalent to the 100/25mcg pre-dispensed doses (contained inside the inhaler) approved in the US.

In September 2012, a regulatory submission for FF/VI under the trade name Relvar Ellipta  was filed in Japan and is currently under review for asthma. FF/VI is not approved or licensed in the European Union or anywhere outside the US and Canada.

In the US, Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of asthma.

In addition to FF/VI, the GSK respiratory development portfolio also includes LAMA/LABA (umeclidinium bromide (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.

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

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

Theravance – is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies.