FDA CRL - ViiV Healthcare Company

On December 19, 2019, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to ViiV Healthcare Company regarding its New Drug Application (NDA 212887) for VOCABRIA® (cabotegravir) 30 mg tablets. The agency cited several unaddressed issues, preventing approval in its current form. A central deficiency related to product quality information for the associated CABENUVA® NDA (cabotegravir + rilpivirine injectable suspension co-pack). Approval of VOCABRIA® is contingent upon resolving these CABENUVA® deficiencies. Other critical areas needing attention include the proposed prescribing information, which requires revisions to meet FDA formatting and content standards. The company must also submit updated carton and container labeling, and formally resubmit the proprietary name, VOCABRIA®, with its response. Significantly, the FDA mandated a comprehensive safety update, as per 21 CFR 314.50(d)(5)(vi)(b). This update must incorporate all new clinical and nonclinical safety data, detailing significant changes, presenting combined adverse event tabulations, providing updated patient exposure data, including case reports for serious adverse events or deaths, and summarizing global safety experience. ViiV Healthcare is required to fully address all deficiencies and resubmit the application within one year. The company may also seek a meeting with the FDA to discuss the path forward for approval. The drug cannot be commercially marketed until official written approval is granted.