Product information and disease description Place of product in therapy Approaches to treatment

Other product development or post-marketing obligations required by the FDA

6 evidence topics · 5 sources

Postmarketing requirements and commitments in an FDA approval letter

No evidence found.

Populations without established safety and efficacy at approval

“The safety and effectiveness of HIBSAGO have not been established in patients less than 18 years of age.” (opens the prescribing information at this quote)
“Insufficient data are available on the safety of HIBSAGO in patients with moderate or severe renal impairment or end stage renal disease (eGFR less than or equal to 59 mL/min/1.73m2).” (opens the prescribing information at this quote)
“The safety and efficacy of HIBSAGO in patients with cirrhosis have not been established.” (opens the prescribing information at this quote)
“The safety and efficacy of HIBSAGO have not been established in patients with hepatitis C virus (HCV) coinfection.” (opens the prescribing information at this quote)
“There are insufficient data on the use of HIBSAGO in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.” (opens the prescribing information at this quote)

Ongoing trial in HIV and HBV coinfection

“This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.” (opens the source at this quote in a new tab)

Ongoing pharmacokinetic study in moderate and severe renal impairment

“The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.” (opens the source at this quote in a new tab)

European Union paediatric investigation plan: agreed measures

Area	Measure
Clinical studies, Study 1 (206839)	“Open label, randomised, controlled study of pharmacokinetics (PK), safety and efficacy of bepirovirsen in children from 2 years to less than 18 years of age with chronic hepatitis B virus (HBV) infection.”
Extrapolation, modelling and simulation studies, Study 2	“Population PK modelling and Exposure-Response study to determine paediatric doses of bepirovirsen for children from 2 years to less than 18 years of age.”
Extrapolation, modelling and simulation studies, Study 3	“PK bridging/extrapolation of efficacy data to support the use of bepirovirsen for the treatment of chronic hepatitis B in children from 2 years to less than 18 years of age.”

European Union paediatric investigation plan: waiver, completion date, and deferral

“the paediatric population from birth to less than 2 years of age;” (opens the source at this quote in a new tab)
“Date of completion of the paediatric investigation plan:” (opens the source at this quote in a new tab)
“By May 2034” (opens the source at this quote in a new tab)

Further development: sequential daplusiran/tomligisiran followed by bepirovirsen

“The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy.” (opens the source at this quote in a new tab)