Ipsen gains accelerated approval for elafibranor for rare liver disease

Mohammed Haneefa Nizamudeen The U.S. FDA has approved Ipsen's ( OTCPK:IPSEY ) Iqirvo (elafibranor) for primary biliary cholangitis, a type of rare liver disease, in combination with ursodeoxycholic acid (UDCA) or as monotherapy.

The drug, a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist, was approved based on the results from the phase 3 ELATIVE trial. The study found that 51% of patients on elafibranor + UDCA achieved the primary endpoint of biochemical response versus 4% for placebo + UDCA. Ipsen is expecting decisions from the European Medicines Agency and the UK's Medicines and Healthcare Products Regulatory Agency on elafibranor in the second half of the year.

Primary biliary cholangitis impacts about 100,000 people in the U.S., most of them women.

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