Shots:

• The approval is based on the P-III (SONICS) & (LOGICS randomized-withdrawal) studies to evaluate Recorlev vs PBO in 166 patients with endogenous hypercortisolemia with Cushing’s syndrome. The product is expected to launch in Q1’22
• Both studies met its 1EPs & 2EPs i.e., reduction & normalization rate of mean UFC without a dose increase & confirmed the efficacy & safety in normalizing & maintaining therapeutic response
• Recorlev is a cortisol synthesis inhibitor & has received ODD from the US FDA & EMA for the same indication. The company has launched the Xeris CareConnection program & provide access to patients including financial assistance, one-on-one support & educational resources

Ref: Xeris | Image: Xeris