GSK and Theravance file for FF/VI approval in the USA and Europe; Talks with Human Genome?

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) announced on Friday that they had submitted regulatory applications in the USA and European Union for the once-daily investigational medicine fluticasone furoate and vilanterol (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a regulatory application for asthma in the European Union.

GSK is looking to replace its top-selling drug Advair (fluticasone and salmeterol), which last year generated global sales of around $8 billion, but has seen revenue growth slow in the USA following FDA warning labels regarding the class of long-acting beta-agonists (LABAs) for the treatment of asthma (The Pharma Letter June 3, 2010). Advair is now off patent in the USA and Europe, but has faced little generic competition so far because of difficulties in copying the inhaled product. The new FF/VI product should reach the market in 2013 and consensus forecasts point to sales of $1.88 billion by 2016, according to Thomson Reuters Pharma.

A Marketing Authorization Application for FF/VI, with the proposed brand name Relvar, administered by a new dry powder inhaler called Ellipta, has been submitted to the European Medicines Agency for the following indications: