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.

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