RAVICTI (glycerol phenylbutyrate), digestive tract and metabolism medicinal product

High clinical benefit in urea cycle disorders, but no demonstrated clinical value over AMMONAPS

• RAVICTI oral solution has been granted marketing authorisation for the treatment of urea cycle disordersinvolving deficiency in carbamyl-phosphate synthase I, ornithine, carbamoyl transferase, argininosuccinate synthetase, argininosuccinate lyase, arginase I and ornithine translocase, hyperornithinaemia-hyperammonaemia-homocitrullinuria syndrome, that cannot be managed exclusively by a low-protein diet and/or by amino acid supplementation.

• RAVICTI has shown itself to be non-inferior to AMMONAPS (sodium phenylbutyrate) for controlling plasma ammonia concentration in children and adults,

• Its safety profile is characterised by gastrointestinal disorders: diarrhoea, flatulence, abdominal pain, vomiting, dyspepsia, abdominal discomfort, nausea and oral discomfort.