By sum­mer sol­stice, we'll know the fate of In­ter­cep­t's NASH drug

In­ter­cept Phar­ma­ceu­ti­cals has an­oth­er date with the FDA, as the reg­u­la­tor will de­cide for a sec­ond time whether to ap­prove the biotech’s drug for pa­tients with pre-cir­rhot­ic liv­er fi­bro­sis due to non­al­co­holic steato­hep­ati­tis, or NASH.

The agency set an ac­tion date of June 22. FDA said no around the same time in 2020.

At stake is an ac­cel­er­at­ed ap­proval for obeti­cholic acid, or OCA, which is al­ready on the mar­ket for pri­ma­ry bil­iary cholan­gi­tis. In­ter­cept and ex-US rights own­er Ad­vanz mar­ket the drug as Ocali­va for the bile duct-de­stroy­ing dis­ease.

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