Antev Receives US FDA Guidance on Teverelix® Phase 3 Trial Design for Treating Advanced Prostate Cancer Patients with Increased Cardiovascular Risk
London, UK, 8 March 2023: Antev Ltd., a late clinical-stage biotech company developing a novel gonadotrophin-releasing hormone (GnRH) antagonist, Teverelix trifluoroacetate (Teverelix), announces that the US Food & Drug Administration (FDA) has provided written guidance on the company’s proposed Phase 3 pivotal trial design. This would be the first Phase 3 trial for a specific label to treat prostate cancer in patients with increased cardiovascular risk, addressing a significant need for prostate cancer drugs with a better cardiac toxicity profile.
