Ipsen S.A. (IPSEY) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has provided positive opinions for Iqirvo and Kayfanda, which are aimed at two rare cholestatic liver diseases.
Iqirvo is recommended for the treatment of primary biliary cholangitis in adults who have not responded sufficiently to ursodeoxycholic acid or as a standalone option for those who cannot tolerate ursodeoxycholic acid. This favorable opinion is mainly based on data from the Phase III ELATIVE trial.
Kayfanda, on the other hand, is recommended for the treatment of cholestatic pruritus in patients with Alagille syndrome aged 6 months and older. The positive recommendation for Kayfanda is backed by data from the ASSERT Phase III clinical trial.
The company stated that the final decisions on the marketing authorization for both Iqirvo and Kayfanda are anticipated in the third quarter of 2024.
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