Gilead Reports the US FDA’s Approval of sNDA for Vemlidy to Treat Hepatitis B Virus (HBV) Infection


The approval of Vemlidy (25mg, QD) tablets in chronic HBV patients (6yrs. & above, at least 25kg) having compensated liver disease was based on the P-II (Trial 1092) study of Vemlidy vs PBO in treatment-naïve & experienced patients (n=88) aged 12-18yrs. (at least 35 kg) & 6-12yrs. (at least 25 kg)
The trial met the 1EP showing HBV DNA <20 IU/mL in 19% vs 0% of patients at wk.24, 37% of them at wk.48 & 61% of them at wk.96
Furthermore, at wk.96, the overall median change from baseline in ALT was -39.5 U/L vs -46.5 U/L & ALT normalization was seen in 54% vs 57% of patients. At wk.24, mean changes in BMD Z-scores were 0.01 & -0.07 (lumbar spine) vs -0.04 & -0.04 (whole body) with a similar mean percent change in bone mineral density

Ref: Gilead | Image: Gilead

Related News:- Gilead Receives the US FDA’s Approval for Vemlidy (tenofovir alafenamide) sNDA to Treat Chronic Hepatitis B Virus Infection

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