Gilead’s Vemlidy (Tenofovir Alafenamide) Receives NMPA (CFDA) Approval for Chronic Hepatitis B Virus (HBV) Infection

 Gilead’s Vemlidy (Tenofovir Alafenamide) Receives NMPA (CFDA) Approval for Chronic Hepatitis B Virus (HBV) Infection

Gilead’s Vemlidy (Tenofovir Alafenamide) Receives NMPA (CFDA) Approval for Chronic Hepatitis B Virus (HBV) Infection

 Shots:

  • 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

Click here to read full press release/ article | Ref: Gilead | Image: Business Insider 

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post