Ipsen and Medison Pharma have secured Health Canada’s approval for Bylvay (odevixibat) to treat pruritus in patients aged six months or older with progressive familial intrahepatic cholestasis (PFIC).

PFIC is a class of hereditary, potentially fatal liver illnesses caused by abnormalities in genes affecting bile secretion.

Bylvay is a once-daily, non-systemic ileal bile acid transport inhibitor. It is designed to act locally in the small intestine and has minimal systemic exposure.

It is said to be the first medication cleared in Canada for pruritus treatment in patients aged six months or older with PFIC.

Ipsen executive vice president and North America president Stewart Campbell said: “Health Canada’s authorisation of Bylvay brings an important medicine to Canadians living with PFIC and their families.

“Bringing new medicines to new markets where unmet need exists illustrates Ipsen’s mission to improve patient lives.”

Medison Pharma, which is headquartered in Israel, and France-based Ipsen are part of a multiregional cooperation that focuses on introducing Bylvay for treating the rare condition. The partnership is pertained to Canada and Israel.

Medison Pharma CEO Gil Gurfinkel said: “At Medison, accelerating patients’ access to innovative treatments is leading all that we do, so we are pleased and proud to bring Bylvay to patients in Canada.

“We work hard, leveraging our multi-regional platform, to be the partner-of-choice for emerging biotech companies seeking to make their products available in international markets.”

In the US, Bylvay was first made available to individuals with PFIC as a therapy option in 2021.

In the European Union, the drug has regulatory clearance to treat PFIC in patients who are six months of age or older.

It was introduced in more than nine nations and has been approved for public reimbursement in several important markets, including Belgium, France, Germany, Italy, and the UK.

Bylvay was also approved in the US in June 2023 to treat cholestatic pruritus in individuals with Alagille syndrome who have been diagnosed as early as 12 months of age.