Dalbavancin (3) – Xydalba®

Acute bacterial skin and soft tissue infections (ABSSSI), from birth to < 3 months

Characteristics

Start date 01.06.2025 – Marketing authorisation: 02.05.2025
Resolution 20.11.2025
INN Dalbavancin
Brand name Xydalba®
Pharm. company Dossier: Advanz Pharma Germany GmbH
New distributor: Advanz Pharma GmbH
G-BA Procedure ID D-1211
ATC code J01XA04 Glycopeptide antibacterials (J01XA)
ICD-10 codes (AIS) A26.0Erythema migrans, A46Erysipelas, A49.0Staphylococcal infection, unspecified site, A49.1Streptococcal infection, unspecified site, H00.0Hordeolum (externum) (internum) of eyelid, H05.0Acute inflammation of orbit, H60.0Boil of external ear, J34.0Cellulitis of nose, K12.20, K61.0Anal abscess, K61.1Rectal abscess, K61.3, K61.4Intersphincteric abscess, L00.0, L00.1, L01.0Impetigo contagiosa, L02.0Cutaneous abscess, furuncle and carbuncle of face, L02.1Cutaneous abscess, furuncle and carbuncle of neck, L02.2Cutaneous abscess, furuncle and carbuncle of trunk, L02.3Cutaneous abscess, furuncle and carbuncle of buttock, L02.4Cutaneous abscess, furuncle and carbuncle of limb, L02.8Cutaneous abscess, furuncle and carbuncle of other sites, L02.9Cutaneous abscess, furuncle and carbuncle, unspecified, L03.01Cellulitis of right finger, L03.02Acute lymphangitis of right finger, L03.10, L03.11Cellulitis of right axilla, L03.2Cellulitis and acute lymphangitis of face and neck, L03.3Cellulitis and acute lymphangitis of trunk, L03.8Cellulitis and acute lymphangitis of other sites, L03.9Cellulitis and acute lymphangitis, unspecified, L08.0Pyoderma, L08.1Erythrasma, L08.8Other specified local infections of the skin and subcutaneous tissue, L08.9Local infection of the skin and subcutaneous tissue, unspecified, N48.2Other inflammatory disorders of penis, N76.4Furuncle of vulva
Alpha-ID codes (AIS) I110434Anal abscess, I11157Scalp abscess, I11160Nasal abscess, I11372Orbital abscess, I11393Eyelid phlegmon, I12312Foot phlegmon, I12313Arm phlegmon, I12332Finger phlegmon, I12333Toe phlegmon, I131856SSS (staphylococcal scalded skin) syndrome with infestation of 30 % of the body surface and more, I13884Erysipelas, I17529Erythrasma, I21012Penile abscess, I21898Ischiorectal abscess, I21901Rectal abscess, I24574Buttock abscess, I25230Infection due to streptococci n.e.c, I27519Skin erysipeloid, I27544Infection due to staphylococci n.e.c, I28516Anal sphincter abscess, I28527Skin abscess, I28588Perifolliculitis, I28913Skin inflammation, I31181Cellulite, I571Pyoderma n.e.c, I572Pyogenic skin infection, I5836SSS (staphylococcal scalded skin) syndrome, I5849Impetigo contagiosa due to staphylococci, I5854Skin abscess of the face, I5861Neck abscess, I5869Torso abscess, I5873Facial phlegmon, I5877Trunk phlegmon, I5895Local skin and subcutaneous infection, I67422Abscess of the upper extremity, I78896Head phlegmon n.c, I78954Oral phlegmon, I90106Abscess of the outer ear, I91021Abscess of the external genital organs in women, I95329Infection of a skin sinus n.c Show more >>
Therapeutic area Infectious diseases
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Xydalba is indicated for the treatment of acute bacterial skin and soft tissue infections (ABSSSI) in paediatric patients from birth up to under 3 months of age.
Subpopulation Indication Comparator
Kinder ab Geburt bis &lt; 3 Monaten mit einer akuten bakteriellen Haut- und Weichgewebeinfektionen (ABSSSI)

Studies and Results

Infants from birth to < 3 months of age with acute bacterial skin and soft tissue infections (ABSSSI)

  • For the medicinal product Xydalba, containing the active ingredient dalbavancin, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 20 April 2023, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
  • Overall assessment
    • The additional benefit is deemed proven.
  • Requirements for a quality-assured application
    • In its resolution pursuant to Section 35a(3), first sentence, of SGB V, the Federal Joint Committee (G-BA) must lay down requirements for the quality-assured application of the reserve antibiotic, taking into account the impact on the resistance situation.
    • Dalbavancin may only be used if there is evidence, or in exceptional cases a strong suspicion, that the infection is caused by methicillin-resistant Staphylococcus aureus (MRSA) and only limited treatment options are available.
    • Qualified consultation shall take place, in accordance with the relevant specialist expertise, with a specialist with additional qualification in infectious diseases, a specialist in internal medicine and infectious diseases, or a specialist in microbiology, virology and infectious disease epidemiology.
    • As a general rule, dalbavancin should not be used as part of a calculated (empirical) treatment regimen.
    • Its strict indication as a reserve antibiotic requires knowledge of the pathogen.
    • Outpatient use: For the appropriate management of MRSA infections and the relevant requirements in clinical practice, please refer to the current recommendations of the RKI.
    • In-hospital management: To ensure compliance with the requirements for a quality-assured application, these must be incorporated into the hospital’s internal regulations and processes.
  • Designation of medicinal products containing new INN in accordance with Section 35a(3), fourth sentence, of SGB V
    • – No designation of medicinal products containing new INN active ingredients that can be used in combination therapy in accordance with Section 35a(3), fourth sentence, of SGB V, as the G-BA has decided to grant an exemption for the assessed medicinal product as a reserve antibiotic in accordance with Section 35a(1c), first sentence, of the SGB V.

Courtesy translation only, please refer to the German original.

Associated procedures



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