- The positive opinion is based on P-III BREEZE-AD program including BREEZE-AD1 & BREEZE-AD2 studies assessing baricitinib as monothx. in mod. to sev. AD patients
- The CHMP’s recommendation also involves a BREEZE-AD4 study assessing baricitinib + topical corticosteroids in patients with mod. to sev. AD who have failed or who are intolerant to or have contraindications to cyclosporine and BREEZE-AD7 study assessing baricitinib + topical corticosteroids in patients with mod. to sev. AD
- The positive opinion marks the first step toward EU approval for baricitinib for patients with AD. If approved, the therapy would become the first JAK inhibitor for AD with expected EC’s decision in the next 2mos.
Click here to read full press release/ article | Ref: Eli Lilly | Image: Bilaterals