In­ter­cep­t's NASH hope­ful gets pre­lim­i­nary thumbs down in FDA brief­ing docs

The FDA has once again raised safe­ty con­cerns around the use of In­ter­cept’s obeti­cholic acid in NASH, con­clud­ing in brief­ing doc­u­ments ahead of an up­com­ing ad­vi­so­ry com­mit­tee meet­ing that it “can­not jus­ti­fy OCA use in NASH sub­jects with Stage 2 or 3 fi­bro­sis.”

In­ter­cept’s push for an ac­cel­er­at­ed ap­proval was first re­ject­ed by the FDA in 2020 af­ter mul­ti­ple de­lays. The drug is mar­ket­ed as Ocali­va in pri­ma­ry bil­iary cholan­gi­tis. At the time, reg­u­la­tors said they were un­cer­tain if its ben­e­fit based on a sur­ro­gate end­point, re­duc­tion in liv­er fi­bro­sis, was enough to out­weigh po­ten­tial risks in NASH, ac­cord­ing to In­ter­cept. Ex­ec­u­tives, how­ev­er, said they were blind­sided.

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