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FDA Approves Livdelzi for Primary Biliary Cholangitis Treatment
Accelerated Approval Granted
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Gilead Sciences Inc.'s Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC).
Pivotal Trial Data
The accelerated approval was based primarily on data from the pivotal placebo-controlled Phase 3 POISE trial, which evaluated the efficacy and safety of Livdelzi in patients with PBC. Results showed that Livdelzi significantly reduced alkaline phosphatase (ALP) levels, a marker of liver damage, after 48 weeks of treatment.
Unmet Medical Need
PBC is a chronic liver disease that affects bile ducts. Livdelzi is the only FDA-approved drug specifically indicated for the treatment of PBC. This approval provides a new treatment option for patients with this debilitating condition.
Outlook
Analysts are optimistic about the potential of Livdelzi. Cantor Fitzgerald estimates that the drug could reach peak annual sales of up to $1 billion. The FDA's accelerated approval allows Livdelzi to be marketed while further clinical trials are ongoing to confirm its long-term benefits.
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