FDA Raises Safety Concerns Over Ocaliva: Serious Liver Injury Linked to Intercept's Troubled Drug
Ocaliva, developed by Intercept Pharmaceuticals, has consistently encountered obstacles in achieving FDA approval for the treatment of primary biliary cholangitis (PBC) because of substantial safety issues. The FDA's identification of serious liver injury cases in patients treated with Ocaliva has compounded the challenges since its launch in 2016. Efforts to approve its use for metabolic dysfunction-associated steatohepatitis were unsuccessful in both June 2020 and June 2023, prompting the cessation of the MASH program and resulting in workforce reductions at Intercept. Despite Intercept's acquisition by Alfasigma, the drug remains under intense scrutiny, especially after receiving a damning advisory committee vote and an FDA Complete Response Letter that underscored safety concerns evident in confirmatory studies[1][2].
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Explore Further
What specific data did the FDA examine to establish the link between Ocaliva and serious liver injuries?
How has Intercept Pharmaceuticals' acquisition by Alfasigma affected the future strategy for Ocaliva?
What are the potential implications of Ocaliva's safety concerns on the drug approval process for other treatments for primary biliary cholangitis?
In what ways has the emergence of Iqirvo and Livdelzi impacted the market for treatments of primary biliary cholangitis?
What are the next steps for regulatory bodies like the FDA in dealing with drugs associated with severe side effects such as Ocaliva?