FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

De­spite some heavy blow­back from an­a­lysts, Mer­ck ex­ecs main­tained an up­beat at­ti­tude about the mar­ket po­ten­tial of its chron­ic cough drug gefapix­ant. But the con­fi­dence may be fad­ing some­what to­day as Mer­ck puts out news that the FDA is hand­ing back its ap­pli­ca­tion with a CRL.

Dubbed by Mer­ck’s de­vel­op­ment chief Roy Baynes as a “pipeline in a prod­uct” with a va­ri­ety of po­ten­tial us­es, Mer­ck had field­ed pos­i­tive late-stage da­ta demon­strat­ing the drug’s abil­i­ty to com­bat chron­ic cough. The drug dra­mat­i­cal­ly re­duced chron­ic cough in Phase III, but so did place­bo, leav­ing Mer­ck’s re­search team with a mar­gin­al suc­cess on the p-val­ue side of the equa­tion.

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