Ipsen: receives two positive opinions from CHMP
(CercleFinance.com) - Ipsen today announced that it has received two positive opinions from the CHMP, the scientific committee of the European Medicines Agency (EMA), for two different drugs for rare cholestatic diseases from the group's growing portfolio.
Iqirvo (elafibranor) is recommended for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients intolerant to UDCA.
Kayfanda (odévixibat) has also received a positive opinion from the CHMP for the treatment of cholestatic pruritus in Alagille Syndrome (AS) in patients aged from 6 months.
The European Commission will now examine the CHMP's recommendations. A final decision on marketing authorisations for Iqirvo and Kayfanda is expected in Q3 2024.
PBC can lead to liver damage and even liver failure in the absence of effective treatments. Today's decision brings us closer to our goal of offering patients Iqirvo, which significantly improves biomarkers of disease progression without worsening symptoms. The positive opinion for Kayfanda also represents a major step forward in our efforts to provide a new treatment option for children with Alagille syndrome, whose liver condition can deteriorate rapidly and who often suffer a very poor quality of life.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
Iqirvo (elafibranor) is recommended for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients intolerant to UDCA.
Kayfanda (odévixibat) has also received a positive opinion from the CHMP for the treatment of cholestatic pruritus in Alagille Syndrome (AS) in patients aged from 6 months.
The European Commission will now examine the CHMP's recommendations. A final decision on marketing authorisations for Iqirvo and Kayfanda is expected in Q3 2024.
PBC can lead to liver damage and even liver failure in the absence of effective treatments. Today's decision brings us closer to our goal of offering patients Iqirvo, which significantly improves biomarkers of disease progression without worsening symptoms. The positive opinion for Kayfanda also represents a major step forward in our efforts to provide a new treatment option for children with Alagille syndrome, whose liver condition can deteriorate rapidly and who often suffer a very poor quality of life.
Copyright (c) 2024 CercleFinance.com. All rights reserved.