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Posted On: 07/07/2022 4:32:49 PM
Post# of 145247
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A less enthusiastic article from a non-Feuerstein writer:
https://www.fiercepharma.com/pharma/intercept...a-analysis
Quote:
But on the issue of whether Ocaliva can actually improve outcomes for NASH patients, the drug once again failed to show a statistically significant benefit at the interim analysis. Only 6.5% of Ocaliva takers enjoyed resolution of NASH with no fibrosis worsening after 18 months, slightly better than 3.5% observed for the placebo group.
Besides, Ocaliva at a lower 10-mg dosing strength didn’t show significant benefits on either endpoint. That’s contrary to the 10-mg dose meeting the statistical significance bar on fibrosis improvement in the original analysis. In its currently FDA-approved primary biliary cholangitis indication, Ocaliva is allowed at 10 mg once daily maximum, and it already carries a black box warning against more frequent dosing .
https://www.fiercepharma.com/pharma/intercept...a-analysis
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