FDA pos­es some tough ques­tions for GSK’s pitch to gain an ap­proval for Nu­cala in COPD

Glax­o­SmithK­line faces a steep, up­hill climb on Wednes­day in its quest to gain an ap­proval for Nu­cala (mepolizum­ab) as a ther­a­py for COPD.

Al­ready ap­proved in asth­ma, top reg­u­la­tors at the FDA laid bare some big prob­lems with the phar­ma gi­ant’s ap­pli­ca­tion on COPD. And they plan to chal­lenge a pan­el of out­side ex­perts on the com­pa­ny’s as­ser­tions that this IL-5 drug is ready for much wider use.

The key is­sues at the FDA, out­lined in their in­ter­nal re­view:

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