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.
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.
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.
Subscribe to MoneyWeek
Subscribe to MoneyWeek today and get your first six magazine issues absolutely FREE

Sign up to Money Morning
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
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%.
BS
Sign up for MoneyWeek's newsletters
Get the latest financial news, insights and expert analysis from our award-winning MoneyWeek team, to help you understand what really matters when it comes to your finances.
-
Which UK region has the most in savings? Average savings by area
The amount people have in their savings differs from region to region in the UK. How does your nest egg compare to those living nearby?
-
Doug and Mary Perkins: Specsavers’ clear-sighted founders
Helped by the deregulation of the sector in the 1980s and brilliant advertising, Mary Perkins and her husband Doug have taken Specsavers to the top of the optometry market