Regulatory

Looking to mount an R&D turnaround, GSK gets slapped down at the FDA for a weak stab at COPD

On the same day that GlaxoSmithKline sought to assure investors that the company’s new R&D team would deliver important drugs in the future, its researchers working on Nucala (mepolizumab) were slapped down in their attempt to gain an added OK for COPD.

A panel of outside experts voted 16 to 3 against a marketing approval. That isn’t binding, but after the internal reviewers at the FDA offered a scathing review of their data, it’s all but a done deal now — barring some unexpected last minute intervention in its favor.

The FDA was clearly unimpressed with GSK’s package.

GSK’s drug failed one late-stage test while scoring a success in the other. With only two Phase III studies in this indication, that left the panel to consider an approval without supporting data from two well-controlled studies — the agency gold standard.

There was no dose response they could find in the two dosage arms, which didn’t help.

The FDA added:

Some key secondary endpoints, such as time to first moderate-to-severe COPD exacerbation showed numerical trends favoring mepolizumab. However, there were no consistent and clinically meaningful differences in severe COPD exacerbation rate, FEV1, or SGRQ between mepolizumab 100 mg and placebo.

GSK’s trial design also spurred questions, with no baseline collection of asthma history — which could have influenced the outcome of the study. How will GSK properly define the patient population for this drug?


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Molecular Templates Austin, TX
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Molecular Templates Austin, TX
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Koneksa Health New York, NY

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