Depemokimab (1) – Exdensur®

a) Adolescents aged 12 to 17 years with severe asthma characterised by type 2 inflammation, as indicated by elevated blood eosinophil counts, which is inadequately controlled despite high-dose inhaled corticosteroids and an additional medicinal product for maintenance therapy

• An additional benefit is not proven.
• As in both studies the existing maintenance therapy was continued despite the uncontrolled asthma and there was no escalation to the appropriate treatment options in accordance with the appropriate comparator therapy, the studies are not suitable for inferring any additional benefit of depemokimab compared with the appropriate comparator therapy.
• Overall, therefore, an additional benefit of depemokimab over the appropriate comparator therapy is not proven for either patient group.

b) Adults with severe asthma characterised by type 2 inflammation, as indicated by elevated blood eosinophil counts, which is inadequately controlled despite high-dose inhaled corticosteroids and an additional medicinal product for maintenance therapy

• The additional benefit is not proven.
• As in both studies the existing maintenance therapy was continued despite the uncontrolled asthma and there was no escalation to the corresponding treatment options in accordance with the appropriate comparator therapy, the studies are not suitable for inferring any additional benefit of depemokimab compared with the appropriate comparator therapy.
• Overall, therefore, the additional benefit of depemokimab over the appropriate comparator therapy is not proven for either patient group.

Courtesy translation only, please refer to the German original.