Strongbridge Biopharma (SBBP) Announces FDA Filing Acceptance of NDA for RECORLEV for Treatment of Endogenous Cushing’s Syndrome

May 13, 2021 7:32 AM EDT

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Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the treatment of endogenous Cushing’s syndrome.

Earlier than anticipated and following Strongbridge’s reporting of first quarter earnings results on May 12, 2021, the Company received the official Day 74 letter from the FDA. Within the Day 74 letter, the FDA set a Prescription Drug User Fee Act (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.

“We are pleased with the FDA's acceptance for filing of the RECORLEV® (levoketoconazole) New Drug Application. We believe this decision reflects the comprehensive clinical evidence that went into the NDA submission, including the positive and statistically significant efficacy and safety results from the multinational Phase 3 SONICS and LOGICS studies evaluating RECORLEV as a potential treatment option for adults with endogenous 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, chief executive officer of Strongbridge Biopharma.



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