Replies to post #249069 on Biotech Values

[DewDiligence]

ICPT will soon have no approved product when Ocaliva for PBC is withdrawn:

https://www.medpagetoday.com/gastroenterology/generalhepatology/111955

On Friday, the [FDA’s] Gastrointestinal Drugs Advisory Committee members voted 10-1 (with three abstentions) that the farnesoid X receptor agonist did not have a favorable benefit-risk profile when used as a second-line treatment for eligible adults with PBC and no contraindications.

As for the question of whether there is clinical benefit of obeticholic acid in the first place, the vote was 13-1 no.

… Safety was an issue for obeticholic acid because the main trial supporting its application…showed trends of excess liver transplants and death in people taking the drug without contraindications.

Ocaliva (obeticholic acid) received FDA accelerated approval for PBC in 2016 (#msg-122964925). The FDA twice rejected Ocaliva as a treatment for NASH.

ICPT is a wholly owned subsidiary of Italy’s Alfasigma.