FDA approves Zavzpret zavegepant nasal spray for the treatment of migraine

The FDA has approved Pfizer’s Zavzpret zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine. Pfizer said that it expects to launch Zavzpret in July 2023.

The FDA accepted the NDA for the zavegepant (formerly “vazegepant”) nasal spray submitted by Biohaven Pharmaceuticals in May 2022. Biohaven was subsequently acquired by Pfizer, along with the US rights to intranasal zavegepant; Pfizer had already acquired ex-US rights to the nasal spray in January 2022.

Pfizer Chief Commercial Officer, President, Global Biopharmaceuticals Business, Angela Hwang commented, “The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications. Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives. Pfizer will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.”

Read the Pfizer press release.

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