LIVDELZI
Generic Name/API: seladelpar
Manufacturer: Gilead
Dosage Forms & Strength & Pack Size:
Capsules: 10 mg, 30’s
Storage:
Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.
LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for the treatment
of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an
inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction of alkaline phosphatase
(ALP). Improvement in survival or prevention of liver decompensation events have not been
demonstrated. Continued approval for this indication may be contingent upon verification and description
of clinical benefit in confirmatory trial(s).
LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
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