Up­dat­ed: In an­oth­er blow for NASH, FDA ad­comm op­pos­es ac­cel­er­at­ed ap­proval of In­ter­cept drug

An FDA ad­vi­so­ry com­mit­tee on Fri­day vot­ed against rec­om­mend­ing ac­cel­er­at­ed ap­proval of In­ter­cept’s once-re­ject­ed NASH hope­ful obeti­cholic acid, say­ing the risk-ben­e­fit pro­file didn’t stack up.

The mem­bers of the FDA’s Gas­troin­testi­nal Drugs Ad­vi­so­ry Com­mit­tee ex­am­ined two ques­tions key to the drug’s ap­proval. They vot­ed 12 -2 (with two ab­sten­tions) that the ben­e­fits don’t out­weigh the risks in NASH pa­tients with stage 2 or 3 fi­bro­sis, and 15 to 1 that an FDA de­ci­sion should be de­ferred un­til ad­di­tion­al da­ta from the on­go­ing piv­otal tri­al comes in.

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