Pfizer Submits Clinical Application in China for Zavegepant, a CGRP Receptor Antagonist Nasal Spray for Acute Migraine Treatment

On March 11, the CDE website showed that Pfizer's new migraine drug Zavegepant had been submitted for clinical trial in China.

Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist, which was approved by the FDA on March 10, 2023, forAcute Treatment of Migraine in Adults With or Without Aura. This product is also the first CGRP receptor antagonist nasal spray for the acute treatment of adult migraine.

The FDA's approval this time is mainly based on the results of two pivotal clinical trials (the Phase II/III BHV3500-201 study and the Phase III BHV3500-301 study). The results of the BHV3500-201 study showed that, compared with the placebo group, the proportion of patients experiencing headache relief was significantly higher in both the Zavegepant 10mg group (15.5% vs 22.5%, p=0.0113) and the 20mg dose group (15.5% vs 23.1%, p=0.0055). The results of the BHV3500-301 study showed that, compared with the placebo group, the proportion of patients experiencing headache relief was significantly higher in the Zavegepant (10mg) group (15% vs 24%, p<0.0001).

Migraine is one of the most common chronic neurovascular disorders globally, characterized by recurrent moderate to severe unilateral and/or pulsating headaches, often accompanied by symptoms such as nausea, sensitivity to light, and/or sound. Based on headache frequency, migraines can be classified into episodic migraine (fewer than 15 headache days per month, with intermittent relief) and chronic migraine (more than 15 headache days per month). Statistics show that the global annual prevalence rate is 15%, affecting over 1.3 billion people, with the incidence in women being approximately three times that of men.

The treatment of migraine is divided into two categories: acute treatment and preventive treatment. Among them, in the field of preventive treatment, CGRP-targeted drugs are star drugs. CGRP is a vasodilatory neuropeptide, and CGRP and its receptors are expressed in the nervous system areas related to the pathophysiology of migraines. Studies have shown that during a migraine attack, CGRP levels increase, and inhibiting the activity of CGRP and its receptor (CGRPR) can alleviate headaches and prevent migraine attacks.

Source: Nature Reviews. Neurology

Currently, there are a total of 8 CGRP-targeted drugs approved for marketing worldwide, including 4 small molecule drugs (Atogepant, Ubrogepant, Rimegepant, Zavegepant) and 4 monoclonal antibodies (Eptinezumab, Erenumab, Galcanezumab, Fremanezumab). However, none of these products have been approved for marketing in China.

Source: Nextpharma Database by PharmaCube

However, Erenumab (Novartis/Amgen), Galcanezumab (Eli Lilly), and Rimegepant (Pfizer) have already submitted applications for market approval in China in April, July, and September 2022, respectively, and are expected to be approved this year. In the CGRP field, only Junshi Biosciences and Boan Biotech in China have made progress; the CGRP monoclonal antibody JS010 developed by Junshi Biosciences was submitted for clinical trials on December 30, 2022.

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