Gilead Receives the US FDA’s Approval for Vemlidy (tenofovir alafenamide) sNDA to Treat Chronic Hepatitis B Virus Infection
Shots:
- The US FDA has approved the sNDA for Vemlidy (25mg, qd) for chronic HBV inf. in pediatric patients aged ≥12yrs. with compensated liver disease
- The approval was based on the 24wk. results from a P-II (Trial 1092) trial of Vemlidy (25mg) vs PBO in 70 treatment-naïve & treatment-experienced patients aged 12 to ≤18yrs. The study met its 1EPs i.e., 21% vs 0% of patients achieved HBV DNA <20 IU/mL @24wks., higher rates of serum ALT normalization
- Additionally, 44% vs 0% achieved ALT normalization with median changes from baseline in ALT of -32.0 vs 1.0 U/L, mean percent changes in bone mineral density from baseline to 24wk. were similar for Vemlidy & PBO treated patients
Ref: Businesswire | Image: Gilead
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