Health Canada has granted approval for Ipsen and Medison Pharma’s Bylvay (odevixibat) to treat pruritus associated with the liver disease progressive familial intrahepatic cholestasis (PFIC).
Bylvay is a once-a-day non-systemic ileal bile acid transport inhibitor and is approved in the US for the same indication
The treatment is indicated for patients aged six months or above.
Bylvay is the first therapy to receive approval in the region to treat pruritus in PFIC patients in this age group.
Ipsen and Medison are part of a multiregional collaboration in Israel and Canada to make Bylvay available.
The latest development is based on findings from the global, double-blind, placebo-controlled, randomised Phase III PEDFIC 1 clinical trial in PFIC patients in which Bylvay met both its pruritus and serum bile acid primary endpoints.
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The treatment was well tolerated, with diarrhoea the most frequently reported gastrointestinal adverse event.
Ipsen North America executive vice-president and president Stewart Campbell stated: “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. We are pleased to work with Medison to get Bylvay to prescribers as soon as possible.”
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