FDA, Regulatory

The pain won’t stop. GSK ends the week with a slapdown on its Nucala application for COPD

GlaxoSmithKline $GSK just completed an unnecessary and embarrassing lap at the FDA with a fresh slapdown.

At a time the company is hoping to begin to demonstrate that the pharma R&D group has begun a long-awaited turnaround, the FDA just completed its latest humiliation on a new application for Nucala with a widely expected complete response letter.

In a short statement out late Friday, the pharma giant noted:

The CRL states that more clinical data are required to support an approval. GSK will work closely with the FDA to determine the appropriate next steps for the supplementary biologics licence application.

The FDA was clearly unimpressed with GSK’s application package. And an expert panel voted 16 to 3 against an approval, leaving no margin for success.

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.

And this is no gold standard drug in COPD. Noted regulators:

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 could GSK properly define the patient population for this drug?

So it’s back to the drawing board for GSK, the Big Pharma company with the worst late-stage pipeline in the major league. The company just laid off 650 staffers to help pay for an R&D renaissance in drug research. They just haven’t done anything about buying something with the savings it’s mapped out since Emma Walmsley was named CEO two years ago.


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