October 2020 News Report Reveals "New" Ocaliva Liver Safety Issue, Which Had Been Under the Radar Previously
Ocaliva (obeticholic acid) was approved by the FDA in 2016 for the treatment of a rare chronic liver disease, primary biliary cholangitis (PBC). Specifically, Ocaliva is FDA-approved for use in combination with ursodeoxycholic acid (UDCA) in adult PBC patients with an inadequate response to UDCA, or as monotherapy in adult PBC patients unable to tolerate UDCA.
Back in 2017 and 2018, the FDA warned that Ocaliva was being incorrectly dosed daily instead of weekly in patients with PBC, and thereby increasing the risk of serious liver injury. For the details of this earlier drug safety issue for Ocaliva, see "FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease".
In October 2020 we first learned about a "new" drug safety issue for Ocaliva -- although it apparently has been on the FDA's radar since at least May 2020. Again, a possible Ocaliva liver-related side effects risk is what has attracted FDA scrutiny.
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It was this October 9, 2020, Endpoints News article, "In another blow to Intercept, the FDA is investigating Ocaliva for potential risk of liver disorder", which brought to light an Ocaliva liver safety FDA evaluation. In relevant part:
Just a month before handing Intercept Pharmaceuticals a CRL for Ocaliva in NASH, the FDA began evaluating the drug for a potential risk of liver disorder in primary biliary cholangitis (PBC) patients. The probe, which launched in May, was disclosed by the company deep down in their latest quarterly report filed with the SEC, and had not otherwise been communicated publicly by Intercept until reports surfaced this week.
[From that Intercept quarterly report: "The FDA has notified us that in the course of its routine safety surveillance, in May 2020 the FDA began to evaluate a newly identified safety signal regarding liver disorder for Ocaliva which the FDA classified as a potential risk...."]
An FDA spokesperson declined to offer any additional information aside from what was posted in FAERS, the agency’s adverse event reporting system, which states they are “evaluating the need for regulatory action.”
It was further reported in this October 2020 Endpoints News article that a spokesman for Intercept, the pharmaceutical company responsible for Ocaliva, said he anticipates the current Ocaliva liver safety FDA evaluation would take about 12 months.
As such, given that this Ocaliva liver safety FDA evaluation began about five months ago, we can look for the ongoing FDA investigation of possible Ocaliva liver disorder side effects to conclude in or about May 2021. Of course, between now and then we will be on the look-out for any significant developments concerning this new / not-so-new drug safety issue for Ocaliva.
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