Isavuconazol (3) – Cresemba®
Mucormycosis, ≥ 1 to ≤ 17 years
Characteristics
| Start date | 01.10.2024 – Marketing authorisation: 22.08.2024 |
|---|---|
| Resolution | 20.03.2025 |
| INN | Isavuconazol |
| Brand name | Cresemba® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-1093 |
| ATC code | J02AC05 Triazole derivatives (J02AC) |
| ICD-10 codes (AIS) | B46.0Pulmonary mucormycosis, B46.1Rhinocerebral mucormycosis, B46.2Gastrointestinal mucormycosis, B46.3Subcutaneous mucormycosis, B46.40, B46.48, B46.5Mucormycosis, unspecified, B46.9Phycomycosis NOS |
| Alpha-ID codes (AIS) | I133403Sepsis due to Mucorales, I14703Mucormycosis, I24214Zygomycosis, I29742Disseminated mucormycosis |
| ORPHAcodes (AIS) | 73263Mucormycosis, 73263Zygomycosis, 73263Disseminated mucormycosis |
| Therapeutic area | Infectious diseases Mucormycosis Orphan |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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|
Cresemba is used for the treatment of children and adolescents aged 1 year and older with mucormycosis in whom treatment with amphotericin B is not appropriate. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children and adolescents aged 1 to ≤ 17 years with mucormycosis for whom treatment with amphotericin B is not appropriate | – (Orphan drug) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (9766-CL-0107.) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
- Clinical trials
- Study 9766-CL-0107 is a single-arm, open-label, multicentre Phase II study investigating the safety, pharmacokinetics and efficacy of isavuconazole in children and adolescents aged 1 to ≤ 17 years with invasive aspergillosis or mucormycosis.
Children and adolescents aged 1 to ≤ 17 years with mucormycosis for whom treatment with amphotericin B is not appropriate
- For children and adolescents aged 1 to ≤ 17 years with mucormycosis for whom treatment with amphotericin B is not appropriate, there is a hint of a non-quantifiable additional benefit, as the scientific data do not permit quantification.
- The strength of the evidence is classified as ‘hint’.
- For the present benefit assessment, the patient population of individuals with mucormycosis is particularly relevant.
- Only one patient with confirmed or probable mucormycosis was included in the study. However, this patient does not correspond to the therapeutic indication under assessment, as treatment with amphotericin B was used as follow-up therapy to the study medication.
- There are therefore no data available on the efficacy of isavuconazole in children and adolescents aged one year and over with mucormycosis for whom treatment with amphotericin B is not appropriate.
- Overall review
- For the present benefit assessment of the treatment of mucormycosis in children and adolescents aged 1 to ≤ 17 years, the results of the pivotal, single-arm, open-label, multicentre Phase II study 9766-CL-0107 investigating the safety, pharmacokinetics and efficacy of isavuconazole in children and adolescents aged 1 to ≤ 17 years with invasive aspergillosis or mucormycosis.
- Overall, the G-BA classifies the extent of the additional benefit as non-quantifiable, as the scientific evidence does not permit quantification.
Courtesy translation only, please refer to the German original.
Associated procedures
| Isavuconazol (3) | Cresemba® | Pfizer Pharma GmbH | Mucormycosis, ≥ 1 to ≤ 17 years | 8 | 100% Hint for non-quantifiable additional benefit Orphan | |
| Isavuconazol (2) | Cresemba® | Pfizer Pharma GmbH | Aspergillosis, ≥ 1 to ≤ 17 years | 40–215 | 100% Hint for non-quantifiable additional benefit Orphan | |
| Isavuconazol (1) | Cresemba® | Basilea Pharmaceutica International Ltd. | Aspergillosis, mucormycosis | 1,293–5,342 | 100% non-quantifiable additional benefit Orphan |
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