Underwhelming results for GSK’s Relovair
GlaxoSmithKline says it is on track to file its respiratory drug Relovair in Europe and the US despite mixed results in late-stage trials.
Relovair is a new treatment for asthma/chronic obstructive pulmonary disease (COPD), aimed to be the follow-up to GSK’s blockbuster Seretide/Advair.
Developed with US biopharma firm Theravance, Relovair is a once-daily combination of long-acting beta agonist vilanterol trifenatate (VI), and GSK’s existing corticosteroid, fluticasone furoate (FF).
But Relovair has failed to prove itself superior to Seretide in the most recent Phase III asthma programme.
In a 12-week placebo-controlled study evaluating lung function in mild to moderate asthma patients, Relovair 100/25mcg did not demonstrate statistically significant improvements compared to FF 100mcg either.
One further study is ongoing, and is expected to end by June.
The COPD programme set Relovair 200/25mcg, 100/25mcg and 50/25mcg against VI 25mcg alone in two exacerbation studies.
In both, Relovair demonstrated numerical increases in lung function compared with VI but not all of these were significant – and GSK is also investigating reports of fatal pneumonia during the study.
GSK nevertheless still intends to file the drug with regulators in mid-2012 for Relovair in COPD in the US and Europe, and for asthma in Europe alone.
The manufacturer says it will continue discussions with the FDA on what’s needed for a US asthma indication.
Investors would undoubtedly have preferred Relovair’s performance to have been more conclusive, but GSK says the 'totality' of the data is encouraging.
“We are pleased to have reached this milestone for Relovair, one of the important assets in our respiratory development portfolio,” said GSK senior vice president Darrell Baker.
“Having undertaken an initial assessment of these data, we believe they support our plan to seek global approvals of this once-daily medicine for the treatment of patients with COPD and asthma,” he added.