- The approval is based on the results of two international P-III 108 and 110 study assessing Vemlidy vs Viread in 1,632 patients with HBeAg-negative and HBeAg-positive HBV disease for duration of 96 wks.
- The study demonstrated improved renal and bone safety symbols when compared to Viread. The US Prescribing Information involves a box warning for Vemlidy with its discontinuation can cause risk of post-treatment severe acute exacerbation of hepatitis B
- Vemlidy 25mg is a qd remedy indicated for chronic hepatitis B in adults and adolescents (aged ≥12 yrs with body weight ≥35 kg) and is approved by FDA for compensated liver disease in adults
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