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

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

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  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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