Intercept’s NASH drug is again rejected by FDA, and now the company will restructure in pivot from disease

In­ter­cept Phar­ma­ceu­ti­cals’ NASH drug obeti­cholic acid was re­ject­ed by the FDA for a sec­ond time on Thurs­day, and the com­pa­ny says it will now dis­con­tin­ue “all NASH-re­lat­ed in­vest­ment” and piv­ot its fo­cus to rare and se­ri­ous liv­er dis­eases.

A re­sub­mis­sion would re­quire, at a min­i­mum, com­plete da­ta from the long-term out­comes phase of its piv­otal RE­GEN­ER­ATE study, In­ter­cept said it was told by the FDA.

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