Supernus Provides Regulatory Update For SPN-830, FDA Has Issued A CRL In Response To The Co's NDA For Spn-830 Indicating That The Review Cycle For The Application Is Complete, But That The Application Is Not Ready For Approval In Its Present Form.
Supernus Provides Regulatory Update For SPN-830, FDA Has Issued A CRL In Response To The Co's NDA For Spn-830 Indicating That The Review Cycle For The Application Is Complete, But That The Application Is Not Ready For Approval In Its Present Form.
Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830. SPN-830 is an investigational apomorphine infusion device for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson's disease (PD) under U.S. Food and Drug Administration (FDA) review.
Supernus Pharmaceuticals, Inc.（納斯達克股票代碼：SUPN）是一家專注於開發和商業化治療中樞神經系統（CNS）疾病產品的生物製藥公司，今天宣佈了針對 SPN-830 的監管更新。SPN-830 是一種研究中的阿撲嗎啡輸液設備，用於持續治療帕金森氏病（PD）的運動波動（“關閉” 發作），正在美國食品藥品監督管理局（FDA）的審查。
The FDA has issued a Complete Response Letter (CRL) in response to the Company's New Drug Application (NDA) for SPN-830. The CRL indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form.
美國食品和藥物管理局已發佈了完整回覆信（CRL），以回應該公司的 SPN-830 新藥申請（NDA）。CRL指出，申請的審查週期已經完成，但申請尚未準備好以目前的形式獲得批准。
The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA. The first area relates to product quality. The Company recently submitted additional product quality data to the FDA which it has not yet reviewed. The second relates to the master file for the infusion device which is proprietary to the device manufacturer. The Company plans to discuss with the device manufacturer the provision of the requested information and the steps required for the resubmission of the NDA for SPN-830. No clinical safety or efficacy issues were identified as a requirement for approval. The FDA completed in February 2024 a successful preapproval inspection of the device manufacturer's facility.
CRL提到了兩個需要FDA進一步審查或向FDA提供額外信息的領域。第一個領域與產品質量有關。該公司最近向美國食品和藥物管理局提交了其他產品質量數據，但尚未對其進行審查。第二個問題涉及輸液設備的主文件，該文件是設備製造商專有的。該公司計劃與設備製造商討論提供所需信息以及重新提交 SPN-830 保密協議所需的步驟。沒有發現臨床安全性或療效問題需要批准。FDA 於 2024 年 2 月成功完成了對設備製造商設施的批准前檢查。
"We remain committed to bringing SPN-830 to the market as an important treatment option for PD patients who experience motor fluctuations associated with off episodes. We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA," said Jack Khattar, President & CEO of Supernus.
“我們仍然致力於將 SPN-830 推向市場，將其作爲與非發作相關的運動波動的 PD 患者的一項重要治療選擇。我們將與美國食品藥品管理局合作解決CRL問題，併成功重新提交我們的 SPN-830 保密協議。” Supernus總裁兼首席執行官傑克·哈塔爾說。