GlaxoSmithKline provides development update on Relovair
26 March 2012 00:00 in Pharmaceutical Company Product News
GlaxoSmithKline has provided a new regulatory and clinical update on Relovair, its new treatment for chronic obstructive pulmonary disease (COPD) and asthma.
The company has completed the phase III registration programme for the fluticasone furoate/vilanterol treatment, following the completion of a study showing its safety and efficacy compared to placebo.
Meanwhile, data has also been published from a pair of non-pivotal 12-week COPD studies comparing the treatment to GlaxoSmithKline's own alternative therapy Advair, with statistically significant benefits demonstrated in one of the two trials.
GlaxoSmithKline intends to continue with its plan to submit regulatory applications for Relovair in the US and Europe in mid-2012.
For asthma, the company will file for European approval around the same time, while discussions remain ongoing with the Food and Drug Administration over the criteria for US authorisation.
Last week, GlaxoSmithKline announced plans to create a new manufacturing facility in Ulverston, as part of major new plans to expand its biopharmaceutical manufacturing capabilities in the UK.
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