FDAnews Drug Daily Bulletin

Eyeing COPD Market Boom, GSK, Theravance Plan Late 2012 Filing for Combo Drug

July 5, 2012
GlaxoSmithKline (GSK) and Theravance plan late 2012 regulatory filings for their new chronic obstructive pulmonary disease (COPD) candidate, saying initial Phase III data supports their plans to chip away at the $5 billion market share dominated by Boehringer Ingelheim’s Spiriva. New safety and efficacy data show the partners’ investigational drug combining umeclidinium bromide (UMEC) and vilanterol (VI) resulted in statistically significant improvements compared with placebo, and in some instances bested Spiriva (tiotropium), GSK and Theravance said Monday.
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