SBBP - FDA accepts Strongbridge Bio's Recorlev application for Cushing's syndrome

Strongbridge Biopharma (SBBP) jumps 6% premarket after the FDA accepted for review Company’s New Drug Application ((NDA)) for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome.The FDA has set a PDUFA target action date of January 1, 2022, which reflects a projected 10-month standard review period. The letter made no mention of a plan to hold an advisory committee meeting.Endogenous Cushing’s syndrome, is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure - often the result of a benign tumor of the pituitary gland.The NDA was based on the positive and statistically significant efficacy and safety results from the Phase 3 SONICS and LOGICS studies evaluating RECORLEV as a potential treatment for Cushing’s syndrome."We are advancing our commercial readiness plans and look forward to potentially bringing a new therapeutic option to the Cushing's syndrome community in the first quarter of 2022,” said John H. Johnson, CEO.

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FDA accepts Strongbridge Bio's Recorlev application for Cushing’s syndrome