Medison and Ipsen announced that Health Canada has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients aged 12 months and older with Alagille Syndrome (ALGS). This approval expands on Bylvay’s initial 2023 Canadian authorization for treating pruritus in Progressive Familial Intrahepatic Cholestasis (PFIC), a severe liver disease.
Alagille Syndrome is a rare genetic disorder affecting multiple organs, including the liver, heart, skeleton, eyes, and kidneys. It is estimated to occur in 1 in every 30,000 live births, with many patients experiencing severe cholestatic pruritus that significantly disrupts sleep and quality of life.
Roberta Smith, President of the Alagille Syndrome Alliance, hailed the approval as a crucial milestone, offering hope and relief to patients and families burdened by relentless itching and discomfort.
The approval was based on data from the global Phase III ASSERT study, the first and only trial of its kind in ALGS patients. The study showed that Bylvay effectively reduces pruritus symptoms within weeks, also improving sleep quality and lowering bile acid levels, while maintaining a favorable safety profile.
Dr. Susan Gilmour, a pediatric liver transplant specialist at the University of Alberta, emphasized the importance of having an additional treatment option to manage the debilitating symptoms of ALGS.
Pamela Minden, Country Manager of Medison Canada, expressed pride in bringing Bylvay to Canadian patients and reiterated the company’s commitment to providing timely access to innovative therapies for rare disease communities.
Medison and Ipsen collaborate across Canada and Israel to deliver Bylvay to patients affected by these rare conditions and their families.