European Commission Approves RELVAR® ELLIPTA® To Treat Asthma And COPD

RELVAR® ELLIPTA® has been given marketing authorization by the European Commission for the treatment of asthma and COPD.  The drug has been jointly developed by GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ:THRX).  The drug is now licensed in 31 European Countries to treat these diseases when certain criteria are present.

Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate and the long-acting beta²-agonist vilanterol “VI”.  It is indicated for the treatment of asthma in adults and adolescents where the condition is not adequately controlled with daily dose, inhaled corticosteroids and “as needed” inhaled short-acting beta²-agonists.  Two strengths of this drug have been approved for this application (92/22mcg and 184/22 mcg.)  It is also approved for the symptomatic treatment of COPD in adults with an exacerbation history despite regular bronchodilator therapy.  The 92/22mcg strength will be used for this application.  Both strengths will be have a once-daily dosage administered using Ellipta, a new, dry powder inhaler (DPI0)

As a part of the 2002 LABA collaboration agreement between the two companies, Theravance will make an initial payment to GSK of $15 million (USD) upon the marketing authorization from the European Commission, and an additional $15 million payment once the new drug is launched in Europe. As part of its assessment, the European Medicines Agency reviewed results of 10 clinical studies in 7,783 patients with COPD and 16 studies in 9,326 patients with asthma.

Source:  http://www.gsk.com/media/press-releases/2013/relvar--ellipta--receives-european-market...