FDA accepted Intercept’s NDA for NASH! https://ir.interceptpharma.com/news-releases/news-release-details/fda-accepts-intercepts-new-drug-application-oca-treatment-pre
How many “cases of death” have been associated with Egrifta with a known dose which have been tolerated by tens of thousands of patients??
Yet FDA has apparently accepted Ocaliva’s NDA for fibrotic NASH patients. A drug which can cause death due to inaccurate dosing guess why due to liver injury.
It will be interesting if approved to see the box warning/warnings.
Again Tesamorelin is safe with a well tolerated dose which can help potentially NASH patients but definitely won’t harm them.
“On September 21, 2017, FDA warned that the liver disease medicine Ocaliva (active ingredient obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.
Since Ocaliva approval in May 2016, FDA received reports of 11 cases of serious liver injury and 19 cases of death associated with Ocaliva. The FDA's Adverse Event Reporting System (FAERS) includes only reports submitted to FDA, so there may be additional cases about which we are unaware.”
https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-liver-injury-ocaliva-obeticholic-acid-rare-chronic