FDA Grants June 15, 2023 PDUFA Date to Albireo for Bylvay® in Alagille Syndrome
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Browsing Tag
Alagille
Incurable liver disease may prove curable: Drug can spur liver regeneration in…
Research led by Associate Professor Duc Dong, Ph.D., has shown for the first time that the effects of Alagille syndrome, an incurable genetic disorder that affects the liver, could be…
Albireo Submits Bylvay® Alagille Syndrome Regulatory Filings to FDA and EMA
- Gold standard Phase 3 ASSERT study supports supplementary filings in the U.S. and EU - ASSERT study demonstrated efficacy of Bylvay (odevixibat) in pruritus, bile acids and sleep with a…
Odevixibat Shows ‘Encouraging Results’ for Kids With Alagille Syndrome
WASHINGTON -- Treatment with odevixibat (Bylvay) led to early, rapid, and sustained improvements in pruritus among…
Albireo annuncia i risultati cardine dello studio di Fase 3 di Bylvay® (odevixibat)…
Miglioramento statisticamente molto significativo dell'endpoint primario del prurito (p=0,002)Significative riduzioni dell'endpoint chiave secondario dei livelli di acidi biliari nel siero…
Albireo informa de datos positivos de primera línea del ensayo de fase 3 sobre…
Mejoría estadísticamente muy significativa en el criterio de valoración principal «prurito» (p = 0,002)Reducciones significativas en el criterio de valoración secundario clave «niveles de…
Albireo Reports Positive Topline Data from Phase 3 Trial of Bylvay® (odevixibat) in…
Highly statistically significant improvement in pruritus primary endpoint (p=0.002)Significant reductions in key secondary endpoint of serum bile acid levels (p=0.001)Substantial…