After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagill
There's been another twist to the tale of Advanz Pharma's efforts to keep its primary biliary cholangitis (PBC) therapy Ocaliva on the market in the EU.
The European Commission has followed the advice of its human medicines committee and revoked the conditional marketing authorisation for Advanz Pharma's Ocaliva therapy for primary biliary
At the start of the year, there had been no new therapies for rare cholestatic liver disease primary biliary cholangitis (PBC) in the US for almost a decade.
In unusual circumstances, Ipsen has been given the green light for its odevixibat drug for severe itching (pruritus) in patients with rare liver disease Alagille syndrome (ALGS) in the EU –
Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the first dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (
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