TGA win lands just in time

 Posted 30 June 2026 AM

With just days to spare before the PBAC meets next month, Ipsen has secured TGA approval for Bylvay, the first medicine specifically approved in Australia for treating cholestatic pruritus in patients with Alagille Syndrome (ALGS) aged six months or older.

Ipsen failed to win a recommendation for Bylvay in ALGS in March but after accepting the early re-entry pathway, the drug will be considered again by the PBAC when it meets over three days from 8 July. Bylvay was listed on the PBS in January for a different indication: progressive familial intrahepatic cholestasis.