Bulevirtide
Bulevirtide is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- Bulevirtide
- Brand Names
- N/A
- Application Number
- Sponsor
- Jubilant HollisterStier LLC
- NDC Codes
- 1
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- N/A
- Active Ingredients
- BULEVIRTIDE ACETATE
Indications and Usage
1 INDICATIONS AND USAGE HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14) ] . An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on participants who achieved a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 14 )