Ipsen announced that Iqirvo (elafibranor) 80 mg tablets have received accelerated approval from the US Food and Drug Administration (FDA) to treat primary biliary cholangitis (PBC) in adults who do not respond well to ursodeoxycholic acid (UDCA) or as monotherapy in patients who cannot tolerate UDCA. For qualified patients in the US, an urgent prescription for Iqirvo may be issued.
This indication has received rapid approval based on a reduction in alkaline phosphatase (ALP). The improvement in survival or prevention of liver decompensation events has not been established. Continued approval for this indication may be subject to verification and description of clinical benefit in confirmatory trial(s). Iqirvo is not indicated for persons who have or develop decompensated cirrhosis (ascites, variceal hemorrhage, or hepatic encephalopathy).
“For a significant number of people living with PBC, available treatments do not control the condition and may exacerbate symptoms of PBC. Left unmanaged, PBC can progress, leading to liver failure and in some cases, the need for a liver transplant,” said Christelle Huguet, executive vice president, head of research and development at Ipsen. “Iqirvo demonstrated statistically significant improvements in biochemical response compared to UDCA alone. Iqirvo is therefore a much-needed treatment option and the first new medicine for PBC in nearly a decade."
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