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Dalbavancine

Xydalba

Extended indication Extension of indication to include the treatment of acute bacterial skin and skin structure infectio
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Dalbavancine
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Bacterial infections
Extended indication Extension of indication to include the treatment of acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients from birth, including paediatric patients aged less than 3 months with suspected or confirmed sepsis associated with skin and subcutaneous tissue infections
Proprietary name Xydalba
Manufacturer Abbvie
Route of administration Intravenous
Therapeutical formulation Powder for solution for infusion
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2024
Expected Registration July 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van EMA-indiening in september 2024 en een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value

Current treatment options Tedizolid, linezolid
Therapeutic value No estimate possible yet
Dosage per administration 22.5 mg/kg (maximum 1500 mg)
References NCT02814916 (DUR001-306)
Additional remarks 22,5mg/kg (maximum 1.500mg) on Day 1. Dalbavancin was administered intravenously over 30 (± 5) minutes.

Expected patient volume per year

References Horizonscan Geneesmiddelen dalbavancine (1).
Additional remarks Het patiëntvolume ouder dan 3 maanden is eerder geschat op maximaal 100 (1). Het patiëntvolume dat in aanmerking komt voor deze indicatieuitbreiding naar baby's jonger dan 3 maanden zal gering zijn.

Expected cost per patient per year

Cost < 760.00
Additional remarks Xydalba, 500mg poeder voor oplossing voor infusie per injectieflacon: €828,40 (inclusief BTW). Voor een toediening voor een baby zal een flacon nodig zijn €760 (exclusief BTW).

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.