Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aimovig (erenumab), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), which can now be used as a preventive treatment for adult migraines in China.
Phase III DRAGON Study Results
The Phase III DRAGON study, which evaluated the drug’s efficacy in Asian populations, demonstrated significant reductions in monthly migraine days for the erenumab group compared to the placebo group during the double-blind treatment period. Specifically, at weeks 4, 8, and 12, the erenumab group experienced decreases of 5.98, 7.39, and 8.19 migraine days, respectively, compared to their baseline. These results highlight the drug’s effectiveness in reducing the frequency of migraines.
Safety and Efficacy Consistency
The safety profile of erenumab in Chinese patients is found to be consistent with the overall safety profile observed in global studies, adding to the confidence in its use for migraine prevention.
Erenumab’s Administration and Global Reach
Administered subcutaneously once a month by the patient, erenumab can take effect within the first week of use, offering a convenient and efficient disease management option for migraine sufferers. Since its initial approval in the US in May 2018, the drug has been approved in over 70 countries worldwide. It was first introduced in the Greater Bay Area (GBA) of China through an early access program in July of the previous year.-Fineline Info & Tech
