California Healthline September 30, 2022
Dr. Steven-Huy Han, a UCLA liver specialist, has prescribed Ocaliva to a handful of patients, although he’s not sure it helps.
As advertised, the drug is lowering levels of an enzyme called alkaline phosphatase in their blood, and that should be a sign of healing for their autoimmune disease, called primary biliary cholangitis. But “no one knows for sure,” Han said, whether less enzyme means they won’t get liver cancer or cirrhosis in the long run.
“I have no idea if the drug will make them better,” he said. “It could take 10, 20, or 30 years to know.”
Ocaliva came to market through an FDA review process created 30 years ago called accelerated approval, which allows pharmaceutical companies to...
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