The U.S. Food and Drug Administration has approved the accelerated use of Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis (PBC) in adults. This approval covers its use in combination with ursodeoxycholic acid (UDCA) for those who have an inadequate response to UDCA, and as a monotherapy for patients who cannot tolerate UDCA, according to a statement from Ipsen (IPSEY).
However, the company advised that Iqirvo is not recommended for individuals who have or develop decompensated cirrhosis, such as ascites, variceal bleeding, or hepatic encephalopathy.
Iqirvo has also been submitted to the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for approval to treat PBC. The final regulatory decisions from the EMA and MHRA are expected in the second half of 2024.
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