Teva Pharmaceuticals Submits NDA in China for Fremanezumab Injection to Prevent Migraine in Adults and Adolescents

Intelligent Finance APP learned on January 22 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) latest announced that Teva Pharmaceutical Industries (TEVA.US) has applied for a new drug under Category 3.1.Remanezumab InjectionThe listing application has been accepted. Public information shows,Fremanezumab is a humanized monoclonal antibody (mAb) that selectively binds to the calcitonin gene-related peptide (CGRP) ligand. This product is indicated for the preventive treatment of migraine in adult patients.

Screenshot source: CDE official website

The CGRP signaling pathway is a popular target for the treatment of migraine. Globally, several antibody therapies targeting the CGRP receptor or CGRP itself have been approved for the preventive treatment of migraine.Rimegepant is a humanized CGRP monoclonal antibody that selectively binds to the CGRP ligand and blocks both α- and β-CGRP subtypes from binding to the receptor.Previous studies have shown that Remanezumab 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 Remanezumab alsoExpected to be used for the prevention of episodic migraine in pediatric and adolescent patients aged 6 to 17.Teva Pharmaceutical Industries Ltd. announced the results of a new Phase 3 clinical study in December 2024. The study evaluated the efficacy and safety of Remanezumab in preventing episodic migraine in pediatric and adolescent patients aged 6 to 17. The results showed that, compared with placebo, Remanezumab demonstrated statistically significant superiority over placebo in terms of efficacy within 12 weeks.Significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) over a 12-week period, with a favorable safety profile consistent with the results observed in the adult population.