GSK completes LAMA/LABA Ph III program; readies for global filings

28 August 2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) say they have completed the Phase III program of an investigational LAMA/LABA involving approximately 6,000 patients with chronic obstructive pulmonary disease (COPD).

LAMA/LABA is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler. UMEC/VI is a once-daily investigational medicine currently under development for the maintenance treatment of COPD.

Last month, GSK and Theravance announced the completion of four pivotal studies for UMEC/VI (The Pharma Letter July 2). The pivotal program for UMEC/VI also includes a 52-week safety study, which is now complete. Two non-pivotal 12-week crossover exercise studies will also be included in the registrational package as they are now also complete. These recently completed studies support GSK’s plans to commence global regulatory submissions for UMEC/VI from the end of 2012.

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