Levo Therapeutics, Inc. – FDA CRL

Elevar Therapeutics, Inc. received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA 216586) for rivoceranib tablet. The FDA determined that the application cannot be approved in its current form due to several critical deficiencies. A primary issue is that rivoceranib's safety and effectiveness have only been established in combination with SHR-1210. Therefore, approval for rivoceranib is contingent upon the regulatory approval of SHR-1210. Additionally, the FDA was unable to complete all required Bioresearch Monitoring (BIMO) clinical inspections due to travel restrictions, deferring them until a resubmission. Comments on proposed prescribing information, carton/container labeling, and the proprietary name are reserved until these primary deficiencies are resolved and the application is deemed otherwise adequate. To address these concerns and facilitate approval, Elevar Therapeutics must comprehensively respond to all identified deficiencies. Key required actions include providing a detailed safety update, encompassing all nonclinical and clinical study data, significant safety profile changes, updated adverse event frequencies, and case report forms for deaths and serious adverse events. The company must also provide updated exposure information and a summary of worldwide safety experience. A resubmission must be clearly marked as such and address all points outlined in the CRL within one year. The product cannot be marketed until the application receives written approval.