IPSEN Australia has announced the listing of Bylvay (odevixibat) on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients six months and older with progressive familial intrahepatic cholestasis (PFIC).
PFIC is a group of rare genetic disorders in which bile acids build up in the liver, causing damage which may result in liver failure.
It typically manifests and is most aggressive in infants and young children.
The disease impacts patients' daily lives through debilitating symptoms including severe pruritus which can result in skin mutilation, loss of sleep, irritability, poor attention and impaired school performance.
Bylvay is a once-daily, oral, ileal bile acid transport inhibitor that reduces reabsorption of bile acid back to the liver.
It is the first and only medicine specifically approved and reimbursed for treating PFIC in Australia and is a welcome alternative to surgical interventions for patients and their families.
"Children with PFIC often endure relentless itching that affects their daily quality of life," said paediatric gastroenterologist, Professor Winita Hardikar, head of liver and intestinal transplantation at Victoria's Royal Children's Hospital and director of the Liver Foundation.
"This includes regular, nightly sleep disturbance, which can have a negative impact on the whole family.
"The reimbursement of Bylvay as a once-daily oral therapy represents a welcomed new option in how we approach this disease and offers hope for patients and families in Australia living with the devastating impact of PFIC," she concluded.
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