(CercleFinance.com) – Ipsen announces that the United States FDA has approved its Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients aged 12 months and older with Alagille syndrome (AGS), cholestatic liver disease rare.
Positive results from the Phase III ASSERT study, presented at the 2022 AASLD meeting, showed that Bylvay provided clinically and statistically significant sustained improvement in pruritus shortly after starting treatment.
Ipsen has also submitted Bylvay for EMA approval for the treatment of SAG in Europe. The CHMP should issue its opinion in the second quarter and the EMA its final regulatory decision in the second half of 2023.
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