Pfizer’s Zavzpret (zavegepant) Receives the US FDA’s Approval for the Treatment of Migraine
- The US FDA has approved Zavzpret, the calcitonin gene-related peptide receptor antagonist nasal spray for migraine with/out aura. The therapy is expected to be available in July 2023
- The approval was based on 2 pivotal studies evaluating Zavzpret. The results showed that Zavzpret was superior to PBO on the co-primary EPs of pain freedom & freedom from most bothersome symptoms @2hrs. post-dose & was well tolerated
- The P-III study published in The Lancet Neurology found that Zavzpret was more effective than PBO across 13 of 17 prespecified secondary outcome measures incl. early time point EPs (relieve pain within 15-30 min., return to normal function in 30min.), return to normal function after 2hrs., durable efficacy EPs (sustained pain freedom, sustained pain relief from 2-48hrs.)
Ref: Pfizer | Image: Pfizer
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