Mer­ck cough drug fails to win ad­comm’s back­ing as FDA rais­es ef­fi­ca­cy ques­tions

The FDA’s Pul­monary-Al­ler­gy Drugs Ad­vi­so­ry Com­mit­tee vot­ed 12 to 1 in sup­port of re­ject­ing Mer­ck’s ap­pli­ca­tion for its chron­ic cough drug gefapix­ant, fol­low­ing agency con­cerns over the drug’s ef­fi­ca­cy da­ta.

The pan­el of out­side ad­vi­sors vot­ed on whether Mer­ck’s da­ta showed gefapix­ant had a clin­i­cal­ly mean­ing­ful ben­e­fit. In the run-up to the ses­sion, FDA staff had cit­ed what they called a small re­duc­tion in cough­ing fre­quen­cy, and re­sults from sec­ondary end­points that they de­scribed as “not sta­tis­ti­cal­ly per­sua­sive.”

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