Xeris’s Recorlev (levoketoconazole) Receives the US FDA’s Approval for Endogenous Hypercortisolemia in adult With Cushing’s Syndrome
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
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