FDA adds new 'do not use' note to In­ter­cep­t's Ocali­va la­bel af­ter a slew of side ef­fect re­ports in cir­rho­sis pa­tients

In­ter­cept has seen noth­ing but hard times the past year af­ter a high­ly tout­ed swing at NASH fell flat at the FDA’s feet last sum­mer. Now, the drug that In­ter­cept hoped would get over the fin­ish line in NASH is fac­ing new safe­ty flags in an­oth­er in­di­ca­tion, and the FDA is tak­ing ac­tion on its la­bel.

The FDA has added a con­traindi­ca­tion to its la­bel for In­ter­cept’s Ocali­va (obeti­cholic acid) to treat pri­ma­ry bil­iary cholan­gi­tis af­ter a slew of side ef­fects in pa­tients with ad­vanced cir­rho­sis and ear­ly cir­rho­sis pa­tients with ex­ist­ing hy­per­ten­sion in the por­tal vein were re­port­ed to the agency, In­ter­cept said Wednes­day.

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