Gilead Launches Livdelzi, a Groundbreaking Inflammatory Liver Disease Treatment, Following FDA Approval ###

FDA Approval:
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare autoimmune liver disease.

Gilead Sciences:
Gilead Sciences, Inc. has launched Livdelzi, marking its first entry into the inflammatory liver disease treatment market. This follows the acquisition of CymaBay Therapeutics, the drug's developer, for $4.3 billion earlier this year.

Indication:
Livdelzi is indicated for adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) or are unable to tolerate UDCA. It is not recommended for patients with decompensated cirrhosis.

Clinical Benefits:
The drug has demonstrated statistically significant reductions in alkaline phosphatase (ALP) levels and pruritus (itching) compared to placebo. It has also shown normalization of ALP values in 25% of trial participants at 12 months, a key marker for liver health.

Market Impact:
The approval of Livdelzi is expected to provide a new treatment option for approximately 130,000 Americans affected by PBC, with GlobalData projecting revenues to reach $558 million by 2030.

Ongoing Trials:
Gilead is conducting further trials, including the AFFIRM study, to confirm the long-term clinical benefits of Livdelzi. Continued FDA approval may be contingent on the outcomes of these trials.

Competitive Advantage:
Livdelzi offers a competitive advantage over existing treatments like Ocaliva, which can increase itching, a common symptom of PBC. Livdelzi has been shown to reduce itching and improve biomarkers of liver disease.