Ocaliva's Updated Label Aligns With Our View That the Market Is Overreacting
The Food and Drug Administration (FDA) is updating Ocaliva’s label to include a black box warning in response to the 19 patient deaths and 11 severe liver injuries reported in September that were mainly due to incorrect dosing prescribed by some doctors. Most importantly, the updated label merely highlights the same warning to reduce dosage in primary biliary cholangitis (PBC) patients with late-stage cirrhosis (estimated 2%-3% of patients) and monitoring regimens that were included before. No a...
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