Bepirovirsen Medicine 04 June 2026 Extended indication Treatment of chronic hepatitis B virus (HBV) infection in adults Therapeutic value Total cost Registration phase Registration application pending Product Active substance Bepirovirsen Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Treatment of chronic hepatitis B virus (HBV) infection in adults Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer GSK Portfolio holder GSK Mechanism of action Antisense oligonucleotide Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05630807 (B-Well 1); NCT05630820 (B-Well 2) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Medicijnkosten Additional remarks De prijs is nog niet bekend. Glecaprevir / pibrentasvir (Marivet)dat voor dezelfde indicatie gegeven wordt heeft een prijs van €31.000 per patiënt per jaar. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks