Bulevirtide

Extended indication	Extension of indication to include treatment of chronic hepatitis delta virus (HDV) infection in paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease for Hepcludex.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Bulevirtide
Domain	Infectious diseases
Reason of inclusion	New medicine (specialité)
Extended indication	Extension of indication to include treatment of chronic hepatitis delta virus (HDV) infection in paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease for Hepcludex.
Proprietary name	Hepcludex
Manufacturer	Gilead
Portfolio holder	Gilead
Mechanism of action	Virus inhibitor
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)

Registration route	Centralised (EMA)
Submission date	November 2023
Expected Registration	September 2024
Orphan drug	Yes
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.