Here are four notes:
1. The FDA approved Ocaliva to treat PBC in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
2. Ocaliva has shown a reduction in alkaline phosphatase in PBC patients but has not established an improvement in survival or disease-related symptoms.
3. Ocaliva is expected to be available to PBC patients in the United States within seven to 10 days. A specialty pharmacy network will distribute it.
4. Ocaliva is the first new treatment the FDA approved for PBC in nearly 20 years.
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