GSK, Theravance respiratory drug approved for use in Europe

The European Commission has granted marketing authorization to GSK and Theravance's drug, Relvar Ellipta, for use across the 31 European countries.

Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2-agonist (LABA), vilanterol "VI" (FF/VI). The drug has been approved for two uses:

• The first is for 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.

• The second use is for 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.

Under terms of the agreement, which began in 2002, Theravance is obligated to make a milestone payment to GSK of $15 million following marketing authorization for Relvar Ellipta from the EC. Theravance will pay a further $15 million to GSK following the launch of Relva Ellipta in Europe.

"For many years GSK has been focused on developing a portfolio of new treatments for patients across the world with asthma and COPD. We are delighted that Relvar Ellipta is now licensed, which means that healthcare professionals across Europe will have the option to prescribe an ICS/LABA that offers 24-hour efficacy from a once-daily dose, delivered in our new Ellipta inhaler."

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise.

"This is yet another important achievement and is testament to our successful partnership with GSK in respiratory disease. We are delighted that another significant regulatory body has granted marketing authorisation for Relvar Ellipta for the treatment of asthma and COPD and look forward to seeing the benefits of this effective once-daily treatment option in these patient populations."

Rick E Winningham, Chief Executive Officer of Theravance.