Ipsen's Iqirvo wins European approval for primary biliary cholangitis [Yahoo! Finance]
GENFIT S.A. - American Depositary Shares (GNFT)
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Source: Yahoo! Finance
the treatment of primary biliary cholangitis (PBC), becoming the first drug approved for the liver disease in nearly a decade. The approval is for Iqirvo in combination with ursodeoxycholic acid in adults who do not respond adequately to ursodeoxycholic acid alone. Patients who are unable to take ursodeoxycholic acid at all may also use Ipsen's drug as a monotherapy, as per a 20 September press release. The decision in Europe follows an accelerated approval granted by the US Food and Drug Administration (FDA) in June this year. Both regulatory greenlights were based on data from the Phase III ELATIVE trial (NCT04526665), which demonstrated patients receiving 80mg Iqirvo plus ursodeoxycholic acid achieved greater treatment benefits compared to a placebo group. The results, published in the New England Journal of Medicine , showed that 13 times more patients in the Iqirvo group achieved the composite primary endpoint of biochemical response. Iqirvo is an oral, peroxisome prolife
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