Posted by Michael Wonder on 08 Jan 2024
Cabaletta Bio receives additional FDA fast track designations for CABA-201 in dermatomyositis and systemic sclerosis
8 January 2024 - Second and third FDA fast track designations for CABA-201, following the systemic lupus erythematosus and lupus nephritis designation, providing the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune diseases.
Cabaletta Bio today announced that the US FDA has granted separate fast track designations to CABA-201, an investigational 4-1BB-containing fully human CD19 CAR T-cell therapy, for the treatment of patients with dermatomyositis to improve disease activity and for the treatment of patients with systemic sclerosis to improve associated organ dysfunction.
