FDA

Struggling in R&D, GSK lines up an FDA pitch on COPD with mixed data

One of the few things that GlaxoSmithKline’s pharma R&D group got right in the last few years was mepolizumab, approved for severe asthma in 2015 and sold as Nucala. And now, with rivals looking to compete over market turf in its core respiratory field, investigators have mapped out a shot at an expansion into the COPD market for patients at high risk of exacerbations.

But hitting that goal will rely on shaky data, with plenty of holes in the evidence and a heavy reliance on a biomarker for disease severity.

Emma Walmsley File photo


Researchers for the pharma giant — which has been regrouping as new CEO Emma Walmsley has been thinking through a change-up in R&D — say that mepolizumab scored on the primary endpoint of cutting the rate of exacerbations in one of two Phase III COPD trials, with an adjusted p-value of 0.036 among patients with a high blood eosoniphil count. But the higher dose didn’t work in their dose-ranging study and the same positive/negative split was seen as investigators tracked the time to first significant exacerbation, a key secondary.

None of the other secondaries hit in the placebo comparison for either trial, including the number of hospitalizations or ER visits as well as the results of a questionnaire.

GSK has had one of the weakest pipelines in Big Pharma, a point that Walmsley underscored with a recent decision to clear the decks in R&D — dumping its other recently approved drug Tanzeum along with a deeply troubled late-stage program for the rheumatoid arthritis sirukumab, which is apparently going nowhere for J&J after a recent negative panel vote. The R&D group continues to pursue new indications for Nucala, though, as the drug gained some traction as new meds in the field line up to vie for a better position.

Steve Yancey, GSK

While the pharma giant’s HIV and vaccines groups have continued to do significant work with new programs, the pharma R&D group has been largely ineffective in stirring any kind of excitement. Walmsley is out to change that, in part by doubling down on cancer after GSK made the questionable decision to swap out its late-stage oncology portfolio in exchange for Novartis’ vaccines group.

Steve Yancey, who leads the development work on mepolizumab for GSK, said:

“We believe the data published today in the New England Journal of Medicine demonstrate the benefits of a personalized medicine approach in the treatment of COPD with mepolizumab, using blood eosinophils as a biomarker. Based on the clinically meaningful reductions in exacerbations shown in these studies, we plan to progress regulatory filings this year.”



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