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GEN News Highlights : Aug 30, 2012

EC Filing for Combo COPD Therapy Planned This Year

Novartis says it is planning to file for regulatory approval of its combination COPD therapy QVA149 in Europe and Japan by the end of this year, on the back of positive data from a fifth Phase III study called Spark. Regulatory submission in the U.S. is projected for the end of 2014. All five trials in the Phase III Ignite program for QVA149 to date have met their primary efficacy, safety, exercise endurance, and exacerbation reduction endpoints. The Phase III development program includes 10 studies in total, involving over 7,000 patients in 42 countries.

QVA149 combines Novartis’ approved long-acting β2-adrenergic agonist, indacaterol maleate (Onbrez® Breezhaler®/Arcapta™ Neohaler™) with NVA237 (glycopyrronium bromide; Seebri® Breezhaler®),an investigational long-acting muscarinic antagonist licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. NVA237 is separately undergoing Phase III development as a once-daily inhaled maintenance therapy for the treatment of COPD.

The 64-week Spark study included 2,224 patients with severe-to-very severe COPD, and compared treatment using either QVA149 or glycopyrronium bromide monotherapy. The study met its primary endpoint of reducing the rate of both moderate-to-severe COPD exacerbations, and also overall exacerbations. Treatment using QVA149 similarly led to a lower rate of moderate-to-severe exacerbations when compared with open-label tiotropium.