GlaxoSmithKline set to submit Relovair to regulators

Anglo-American drugs giant GlaxoSmithKline and US counterpart Theravance said the phase III registration programme for the once-daily respiratory medicine, Relovair, in patients with chronic obstructive pulmonary disease (COPD) has been completed.

By MoneyWeek

published 9 January 2012

in Features

Additionally, all but one of the pivotal studies in patients with asthma have been completed.

For COPD, Glaxo intends to submit regulatory applications in the US and Europe in mid-2012.

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For asthma, Glaxo plans to submit an application in Europe in mid-2012 and will continue discussions with the US Food and Drug Administration on the regulatory requirements for a US asthma indication.

The COPD programme included two 52-week "exacerbation" studies each of which randomised approximately 1,620 patients. In the two studies in the COPD programme Relovair at all doses performed better than its comparator Vilanterol. Despite the success GSK is investigating reports of fatal pneumonia amongst patients who used Relovair, primarily at the 200/25mcg dose.

The asthma study programme is still waiting on results comparing the efficacy of Relovair against fluticasone propionate and a placebo. That study is expected to complete in the first half of 2012.

GSK admits a 24-week "superiority study" of Relovair against Seretide in asthma patients "did not meet the predefined threshold for superiority". GSK describes this study as "non-pivotal".

In the last 12 months GlaoSmithKline shares have climbed 21%.