Telix has reached an agreement with the U.S. Food and Drug Administration (FDA) on a resubmission plan for its New Drug Application (NDA) for Pixclara (TLX101-CDx; Floretyrosine F-18 or F-18 FET), an investigational agent for glioma imaging.
The FDA rejected the NDA in late April.
Telix said that it has received detailed feedback from the FDA regarding the Pixclara resubmission package. The resubmission will include an additional confirmatory efficacy study analysis of the existing data, which the company believes will meet the FDA’s request for additional evidence to supplement the NDA, as well as address matters cited in the Complete Response Letter (CRL).
According to the Melbourne, Australia-based firm, the NDA will be resubmitted during the fourth quarter of 2025.
Following successful resubmission, the FDA will designate a new Prescription Drug User Fee Act (PDUFA) date for Pixclara. According to Telix, the agency has acknowledged the unmet medical need and has indicated that an expedited review is likely to be granted on this basis, subject to submission review.
The company said that it is committed to providing ongoing patient access to Pixclara through the FDA-approved expanded access program (EAP) during the regulatory approval process.
