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Https Www Gilead Com News And Press Press Room Press Releases 2024 8 Gileads Livdelzi Seladelpar Granted Accelerated Approval For Primary Biliary Cholangitis By Us Fda

Gilead Sciences' Livdelzi Receives Accelerated Approval from FDA

Breakthrough Treatment for Primary Biliary Cholangitis

Significant Improvements in Liver Disease Progression and Pruritus

Foster City, CA, August 14, 2024 – Gilead Sciences Inc. (GILD) announced today that the US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. Livdelzi is a once-daily oral medication that targets the underlying causes of PBC, a chronic autoimmune liver disease. In clinical trials, Livdelzi demonstrated significant improvements in liver disease progression and reduced pruritus, a common and debilitating symptom of PBC. “This approval is a major milestone for the treatment of PBC and provides hope for patients who have been underserved by current therapies,” said Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences. “Livdelzi has the potential to significantly improve the lives of PBC patients by halting disease progression and reducing pruritus.” The FDA's accelerated approval is based on data from the Phase 3 STELLAR-4 and STELLAR-3 clinical trials. In STELLAR-4, Livdelzi met the primary endpoint of significantly reducing liver fibrosis progression at week 24 compared to placebo. In STELLAR-3, Livdelzi significantly improved pruritus at week 12 compared to placebo. The recommended dosage of Livdelzi is 10 mg once daily. Livdelzi is generally well-tolerated, with the most common adverse events being diarrhea, nausea, and fatigue. Gilead is committed to providing access to Livdelzi for all eligible patients. The company has established a patient assistance program to help uninsured and underinsured patients access the medication. For more information about Livdelzi, please visit www.gilead.com.

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