U.S. FDA Grants Priority Review For Ipsen's New Drug Application For Elafibranor For The Treatment Of Rare Cholestatic Liver Disease, PBC
Portfolio Pulse from Benzinga Newsdesk
The U.S. FDA has granted priority review for Ipsen's new drug application for elafibranor, aimed at treating the rare cholestatic liver disease PBC. The PDUFA date is set for June 10, 2024. Additionally, the EMA has validated the MAA for elafibranor, marking it as the first novel second-line treatment for PBC filed in the E.U. and U.S. in nearly a decade.
December 07, 2023 | 6:45 am
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Ipsen's elafibranor has been granted priority review by the FDA for the treatment of PBC, a rare liver disease, with a PDUFA date set for June 10, 2024. The EMA has also validated the MAA for the drug.
The FDA's priority review designation for Ipsen's elafibranor suggests a positive outlook on the drug's potential, likely leading to increased investor confidence and a positive short term impact on Ipsen's stock price. The validation by the EMA further supports the drug's credibility and potential market reach, enhancing its significance.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100