FDA CRL - AbbVie Inc.

The FDA issued a Complete Response Letter (CRL) to AbbVie Inc. regarding its New Drug Application (NDA 216962) for Vyalev (foscarbidopa and foslevodopa) Solution for Infusion, submitted on May 19, 2022. The agency identified several deficiencies preventing approval, primarily concerning the associated Vyafuser delivery system. Key issues included an incomplete Instructions for Use (IFU) document, lacking critical information on factors affecting infusion flow accuracy (e.g., head height, backpressure) as recommended by FDA guidance. The application also exhibited inadequate testing and justification for Essential Performance Requirements (EPRs), with concerns regarding software component verification and reliability. Furthermore, the FDA found insufficient details and testing for the infusion pump's alarm and notification system, noting a lack of comprehensive alarm triggers, thresholds, and remediation steps. There was also an unclear rationale for assigning low priority to critical alerts such as "Low battery" or "Priming error," which could delay therapy. Durability testing was deemed inadequate for assessing EPRs after worst-case scenarios, and battery operating time testing lacked sufficient data for worst-case conditions and the battery's full lifetime. To achieve approval, AbbVie must revise the patient IFU, provide detailed rationales and comprehensive testing results for EPRs and all alarm systems, including re-evaluating and justifying alarm priority levels, and conduct robust reliability and battery performance testing for both unaged and aged infusion pumps.