Two years af­ter CRL, In­ter­cept will meet with FDA lat­er this month to dis­cuss new analy­sis of NASH drug

In­ter­cept Phar­ma­ceu­ti­cals is meet­ing with the FDA lat­er this month in the biotech’s bid to re­sub­mit its drug, obeti­cholic acid or OCA, for liv­er scar­ring due to NASH.

The FDA re­ject­ed the drug in June 2020 af­ter mixed Phase III re­sults, but In­ter­cept said Thurs­day it has tak­en a new look at the on­go­ing late-stage study and the biotech thinks it has the da­ta to sup­port a sec­ond shot. In the new analy­sis of the Phase III study, In­ter­cept once again tout­ed a pri­ma­ry end­point win in the high-dose 25 mg group, which com­prised 308 of the 931 over­all pa­tients.

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