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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.