Dossier assessment
AR101 (Peanut allergy) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
AR101 (Peanut allergy) - Benefit assessment according to §35a Social Code Book V
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Dossier assessment
AR101 (Peanut allergy) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
Indication:
Patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy
Result of dossier assessment:
Proof of lesser benefit
Press releases
Hyposensitisation with AR101 for peanut allergy: proof of lesser benefit
In the patient-relevant outcomes, only disadvantages compared to a peanut-avoiding diet alone were shown for 4- to 17-year-olds. An advantage is only shown in one artificial surrogate outcome.
Additional information
Federal Joint Committee (G-BA)
2022-04-07 A G-BA decision was published.
Project details
- Project no.
- A21-135
- Commission
- Commission awarded on 15.10.2021 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Immune system and infections
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.
Connected Projects
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Dossier assessment
AR101 (peanut allergy, 1 to 3 years) – Benefit assessment according to §35a Social Code Book V
Status: Commission completed