Teva Pharmaceutical Industries Limited Sponsored ADR (TEVA.US) has applied for listing in China, with the potential to significantly improve symptoms of migraine headache in patients.

On January 22, the latest announcement on the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) stated that the market application for Teva Pharmaceutical Industries Limited Sponsored ADR (TEVA.US) 3.1 class new drug fremanezumab injection has been accepted. Public information shows that fremanezumab is a humanized monoclonal antibody (mAb) that selectively binds to the calcitonin gene-related peptide (CGRP) ligand. This product is suitable for the preventive treatment of migraine in adult patients. The CGRP signaling pathway is a popular target for migraine treatment, and there have been several CGRP receptor or antibody therapies approved globally for preventive treatment of migraine. Fremanezumab is a humanized CGRP monoclonal antibody that selectively binds to the CGRP ligand and blocks the binding of two CGRP subtypes (- and -CGRP) to the receptor. Previous studies have shown that fremanezumab can significantly reduce the number of headache days in patients with chronic migraine (CM) and episodic migraine (EM), with good safety. It is worth mentioning that fremanezumab is also expected to be used for the prevention of episodic migraine in children and adolescents aged 6-17. Teva announced new phase 3 clinical trial results in December 2024. The study evaluated the efficacy and safety of fremanezumab in preventing episodic migraine in children and adolescents aged 6-17. The results showed that compared to placebo, fremanezumab was statistically superior to placebo in terms of efficacy within 12 weeks, significantly reducing monthly migraine days (MMD) and monthly headache days (MHD) in 12 weeks, with good safety consistent with the results observed in adults.