U.S. FDA Approves Bylvay® for Patients Living with Cholestatic Pruritus Due to Alagille Syndrome

Ipsen has received approval from the US Food and Drug Administration (FDA) for Bylvay, a drug used to treat cholestatic pruritus in patients with Alagille syndrome aged 12 months or older. This marks the second rare cholestatic liver disease indication for Bylvay in the US after progressive familial intrahepatic cholestasis related pruritus in 2021. The approval was based on positive data from t..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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FDA Action Alert: BMS, GSK, Ironwood, Ipsen/Albireo

The FDA has four target action dates this week, including approvals for drugs to treat functional constipation, Alagille syndrome, myelofibrosis and symptomatic obstructive hypertrophic cardiomyopathy. Ironwood Pharmaceuticals' Linzess is set to be approved as a treatment for functional constipation in children aged 6-17 years on June 14th. Albireo's Bylvay may also receive approval on June 15th..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 13.
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