FDA grants accelerated approval to Ipsen's Iqirvo (elafibranor) for Primary Biliary Cholangitis (PBC) treatment.
FDA grants accelerated approval to Ipsen's Iqirvo (elafibranor) for Primary Biliary Cholangitis (PBC) treatment in adults. This is the first drug developed by GENFIT to receive FDA approval, and Ipsen will market and commercialise it under the trademark Iqirvo. The approval is based on a reduction in alkaline phosphatase (ALP) levels; continued approval may be subject to further evaluation of survival and prevention benefits.
June 10, 2024
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