logo
Share SHARE
FONT-SIZE Plus   Neg

GlaxoSmithKline, Theravance Complete Phase III Programme Of LAMA/LABA

GlaxoSmithKline plc and Theravance Inc. (THRX) announced the completion of the phase III programme of an investigational LAMA/LABA involving approximately 6,000 patients with chronic obstructive pulmonary disease.

LAMA/LABA is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide, or UMEC, a long-acting muscarinic antagonist, or LAMA, and vilanterol, or VI, a long-acting beta2 agonist, or LABA, administered using the ELLIPTA inhaler. The LAMA/LABA Studies investigate the 52-week parallel group safety study evaluated the long-term safety and tolerability of UMEC 125mcg alone and the combination UMEC/VI 125/25mcg compared to placebo in approximately 500 patients.

On 2 July 2012, GSK and Theravance announced the completion of four pivotal studies for UMEC/VI. The pivotal programme 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. The companies said these recently completed studies support GSK's plans to commence global regulatory submissions for UMEC/VI from the end of 2012.

The companies said full results of these studies will be presented at future scientific meetings.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
German steel giant ThyssenKrupp AG reported a loss in its first quarter, compared to last year's profit as sales and orders were hurt by sharp deterioration in materials businesses. The company said its overall performance in the first quarter was within its full-year forecast corridor. Looking ahead, the company continues to expect higher net income and flat sales for fiscal 2016. German lender Commerzbank AG reported a profit in its fourth quarter, compared to last year's loss, particularly benefited by lower loan loss provisions. Chairman Martin Blessing noted that its for the first time in five years that the bank attained a net profit of more than 1 billion euros. Looking ahead, for fiscal 2016, the bank expects a slight increase in net profit from the prior year. Activision Blizzard Inc. (ATVI) on Thursday reported a drop in profit for the fourth quarter, as revenues declined reflecting weak demand for Skylanders SuperChargers and Guitar Hero Live. The video game publisher's profit and revenues fell short of Wall Street estimates. Moving ahead, the company detailed...
comments powered by Disqus
Follow RTT