雅虎香港財經 Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease
On Monday, Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) announced a regulatory update for SPN-830, an investigational apomorphine infusion device under FDA review for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson’s disease (PD).
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 still needs to be prepared for approval in its present form.
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 preapproval inspection of the device manufacturer’s facility.
In October 2022, the FDA granted a CRL for the SPN-830 marketing application when the agency said it required additional information and analysis related to the infusion device and drug product, including labeling, product quality and manufacturing, device performance, and risk analysis.
In October 2023, Supernus Pharmaceuticals resubmitted, and in November, the FDA acknowledged the resubmission of the application for SPN-830.
SUPN stock fell as much as 9% during the premarket session.
Price Action: SUPN shares are down 1.61% at $33.01 on the last check Monday.
Photo by Louis Reed via Unsplash
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