Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Re-submit Following Additional Data Analyses
Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S. Food and Drug Administration (FDA), withdrawal of the New Drug Application (NDA) for palovarotene.
- Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S. Food and Drug Administration (FDA), withdrawal of the New Drug Application (NDA) for palovarotene.
- As a result, Ipsen has therefore confirmed their withdrawal of the NDA for palovarotene.
- After recent discussion with FDA, Ipsen plans to resubmit to the FDA upon completion of the additional data analyses.
- The target regulatory action date assigned by the FDA under a Priority Review status for palovarotene was 30 November 2021.