TEVA's Remicade Injection for the Treatment of Migraine in China Filed for Approval, May Significantly Improve Patient Symptoms

On January 22, the National Medical Products Administration's (NMPA) Center for Drug Evaluation and Research (CDE) website announced that Teva Pharmaceutical Industries Ltd. (TEVA.US) had received approval for its application for the new drug fremanezumab injection, a 3.1 class new drug. According to public information, fremanezumab is a humanized monoclonal antibody (mAb) that selectively binds to the calcitonin gene-related peptide (CGRP) ligand. The product is indicated for the preventive treatment of migraine in adult patients. The CGRP signaling pathway is a hot target for the treatment of migraine, and several antibodies targeting CGRP receptors or CGRP itself have been approved for the prevention of migraine worldwide. Fremanezumab is a humanized CGRP monoclonal antibody that selectively binds to the CGRP ligand and blocks the binding of two CGRP subtypes (α-CGRP and β-CGRP) to their receptors. Previous studies have shown that fremanezumab can significantly reduce the number of headache days in patients with chronic migraine (CM) and episodic migraine (EM), and its safety is good. It is worth noting that fremanezumab may also be used to prevent migraine in children and adolescents aged 6-17. Teva Pharmaceutical Industries Ltd. announced in December 2024 that it had completed a new phase 3 clinical study. The study evaluated the efficacy and safety of fremanezumab in preventing migraine in children and adolescents aged 6-17. The results showed that fremanezumab was statistically significantly more effective than placebo in reducing monthly migraine days (MMD) and monthly headache days (MHD) over 12 weeks, and its safety was consistent with that observed in adult populations.