The European Medicines Agency said there were exceptional circumstances for approving Kayfanda to treat pruritus in patients with the rare genetic disorder.
should be granted a marketing authorization in the Europe an Union under what the Europe an Medicines Agency termed exceptional circumstances.Alagille syndrome is a rare genetic disorder associated with abnormalities of the liver, heart, eyes, kidneys, and skeleton. Most people with the condition have mutations in one copy of theThe active substance of Kayfanda is odevixibat, a reversible and selective inhibitor of the ileal bile acid transporter that acts locally in the distal ileum.
The CHMP endorsed available evidence suggesting that Kayfanda reduces the concentration of serum bile acids in patients with Alagille syndrome, easing pruritus and thereby improving sleep quality. The full indication for authorizing Kayfanda is the treatment of cholestatic pruritus in patients with Alagille syndrome aged 6 months or older.In exceptional circumstances, the EMA may recommend granting an authorization subject to certain specific obligations, which need to be reviewed each year.
Gallbladder Disease Drug/Treatment Safety Drug Safety Treatment Safety Drug Development Drug Discovery Drug Pipeline Drug Development Pipeline Drug Registries Drug Registry Drug Regulation Toxicology Toxicity Poisoning Toxins Alagille Syndrome Pruritus Pruritis Itch Genomics Genomic Medicine Europe European Genetic Disorder Bile Gall Genetics Pain Management Sleep
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