Ipsen In Pole Position For Rare Liver Disease
The FDA is set to make a decision on elafibranor for primary biliary cholangitis by June next year, which could give Ipsen a head start over CymaBay's seladelpar.
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Adding to its liver disease portfolio, Gilead agreed to pay a 27% premium for CymaBay and seladelpar, which has a 14 August FDA action date to compete in second-line primary biliary cholangitis.
CymaBay and Genfit have been positioning their failed NASH candidates, both PPAR agonists, for approval in second-line primary biliary cholangitis. Analysts call both approvable, but say CymaBay’s drug has a better overall profile.
The French company plans to refile Bylvay for Alagille syndrome under a new brand name after the EMA's Committee for Orphan Medicinal Products said the drug did not meet its 'significant benefit' criteria.