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US FDA approves Pfizer's nasal spray for migraine

Published 03/10/2023, 07:55 AM
Updated 03/10/2023, 03:11 PM
© Reuters. FILE PHOTO: Pfizer logo is seen in this illustration taken, May 1, 2022. REUTERS/Dado Ruvic/Illustration/

By Khushi Mandowara

(Reuters) -The U.S. Food and Drug Administration on Friday approved Pfizer Inc (NYSE:PFE)'s nasal spray for migraine, giving patients access to a potentially fast-acting pain-relief option for headaches.

The drug, Zavzpret, was approved for the treatment of acute migraine, the company said. Pfizer gained the drug as well as FDA-approved oral migraine pill Nurtec ODT, through its $11.6 billion buyout of Biohaven Pharmaceutical last year.

Pfizer has forecast peak sales from its migraine pipeline to be around $6 billion.

Zavzpret, to be launched in July, would be comparable in price to other FDA-approved migraine medicines that belong to the same class of drugs, Pfizer told Reuters.

The drug, also known as zavegepant, will be competing with rivals from AbbVie Inc (NYSE:ABBV), Eli Lilly (NYSE:LLY) and Co, Amgen Inc (NASDAQ:AMGN) and Teva Pharmaceutical (NYSE:TEVA) that are also calcitonin gene-related peptide (CGRP) inhibitors.

"The (Pfizer) drug has two main advantages over the older CGRP antagonists: it is safe for people with cardiovascular risk factors, and second, it does not cause medication overuse headache," said Dr Emad Estemalik, psychiatrist at Cleveland Clinic.

A nasal spray would also benefit patients who are unable to swallow a pill, Estemalik said.

Pfizer is hoping to gain a competitive edge in the migraine drug category with Zavzpret, which Biohaven has called the "Epipen of migraine", for its quick action.

Zavzpret's approval was based on late-stage study data that showed the drug was superior in 13 of 17 goals when compared to placebo, including pain relief in 15 minutes and normal function at 30 minutes.

© Reuters. FILE PHOTO: Pfizer logo is seen in this illustration taken, May 1, 2022. REUTERS/Dado Ruvic/Illustration/

About 39 million people in the United States suffer from migraine, according to the Migraine Research Foundation.

Pfizer's shares were marginally up at $39.75 in noon trading.

 

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