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Jul 2, 2012

GSK, Theravance Expect COPD Drug Filing with FDA by Year End

  • GSK and Theravance reported positive data from four pivotal trials evaluating their investigational combination long-acting muscarinic antagonist/long-acting beta agonist (LAMA/LABA) drug in over 4,000 patients with chornic obstructive pulmonary disease (COPD). The firms say they now project starting global regulatory filings ahead of schedule, from the end of 2012.

    The once-daily dry powder inhaled drug UMEC/VI combines GSK’s LAMA umeclidinium bromide (UMEC/GSK573719) with the LABA vilanterol (VI), which the firms selected as a lead candidate through their LABA collaboration, originally signed in 2002. The four reported 24-week UMEC/VI studies included over 4,000 COPD patients and evaluated and compared UMEC/VI, VI, and UMEC either in comparison with placebo or with tiotropium. The results showed that UMEC/VI led to greater improvements in FEV1 than either component alone or tiotropium.

    Data are now awaited from a 52-week safety study, and two replicate 12-week crossover exercise studies. “We are very encouraged by the results of these initial studies for our LAMA/LABA, an important cornerstone of our broad respiratory development portfolio,” comments Darrell Baker, svp, respiratory portfolio optimization leader at GSK. “Subject to successful completion of the ongoing studies we plant to commence global regulatory filings from the end of this year.”

    UMEC/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes Relovair™ (fluticasone furoate/vilanterol, or FF/VI), VI monotherapy, and muscarinic antagonist-beta2 agonist (MABA) GSK961081, developed in collaboration with Theravance, as well as GSK's investigational FF monotherapy, UMEC monotherapy, and anti-IL5 MAb (mepolizumab). GSK says the latest Phase III UMEC/VI trial data will also help support its ongoing development of the UMEC monotherapy, for which it projects initiative global filings in 2013.

    GSK licensed Theravance’s MABA program for the treatment of COPD in 2005, and in 2011 the firms expanded the MABA program by adding six additional preclinical MABA compounds discovered by Theravance. The partners established their collaboration to develop once-daily LABA candidates products for the treatment of COPD and asthma back in 2002. The collaboration resulted in the selection of VI as the inhaled LABA to be developed for once-daily administration both as a single product for the treatment of COPD and as part of the combination medicine Relovair, and the LAMA/LABA combination GSK573719/VI.


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