Mer­ck to face FDA ad­comm in No­vem­ber over pre­vi­ous­ly re­ject­ed po­ten­tial chron­ic cough drug

The FDA an­nounced this morn­ing that on Nov. 17 it will hold an ad­vi­so­ry com­mit­tee meet­ing to take an­oth­er look at Mer­ck’s gefapix­ant for chron­ic cough.

While Eu­ro­pean reg­u­la­tors signed off on gefapix­ant in Ju­ly, the oral tablets ran in­to a com­plete re­sponse let­ter from FDA back in Jan­u­ary 2022, with the com­pa­ny say­ing FDA sought “ad­di­tion­al in­for­ma­tion re­lat­ed to mea­sure­ment of ef­fi­ca­cy. The CRL was not re­lat­ed to the safe­ty of gefapix­ant.”

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