Shots:

• 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.

­ Ref: Eli Lilly | Image: Bilaterals