Summary
- FDA grants accelerated approval for Livdelzi (seladelpar) by Gilead Sciences, Inc. for the treatment of primary biliary cholangitis (PBC).
- Livdelzi is approved to be used in combination with ursodeoxycholic acid (UDCA) for adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
- The approval was based on the Phase 3 RESPONSE study, where participants taking Livdelzi showed significant improvement in biochemical response and ALP values compared to those taking placebo.
- Livdelzi is positioned to challenge the current PBC standard of care and is the only treatment to demonstrate significant and durable improvements in pruritus and cholestasis markers in Phase 3 trials.
- The most common adverse events with Livdelzi include headache, abdominal pain, nausea, abdominal distension, and dizziness, with no treatment-related serious adverse events reported.
FDA has approved a new drug called Livdelzi to treat a liver condition called primary biliary cholangitis (PBC). This condition affects mostly women and can lead to liver damage if left untreated. Livdelzi is a medication that can help improve symptoms like itching and fatigue in people with PBC.
The approval was based on a study where participants taking Livdelzi showed better results in terms of liver function compared to those taking a placebo. Livdelzi was able to reduce a marker of liver damage called alkaline phosphatase (ALP) and improve symptoms like itching.
It is important to note that Livdelzi is not recommended for individuals with severe liver damage. The drug has shown promising results in clinical trials and is now available for those who may benefit from it.
Gilead Sciences, the company behind Livdelzi, is also committed to providing support and resources for patients prescribed with the medication. The company is dedicated to advancing treatments for liver diseases and improving the lives of those affected by these conditions.
Overall, the approval of Livdelzi offers hope for individuals living with PBC and marks a significant step forward in the treatment of this rare liver disease.
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Gastroenterology, Internal Medicine, Pharmacists, FDA Approval, Primary Biliary Cholangitis