Gilead Reports the US FDA’s Approval of sNDA for Vemlidy to Treat Hepatitis B Virus (HBV) Infection
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
