USA — The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura.
As the first and only nasal spray approved to treat migraine, Zavzpret is a third-generation, selective, and structurally unique small molecule calcitonin gene-related peptide receptor (CGRP) receptor antagonist that is currently being clinically developed with oral and intranasal formulations.
According to the company, this regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment.
Pfizer Global Biopharmaceuticals Business President and Chief Commercial Officer, Angela Hwang, stated that “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.”
This approval was granted by the US Food and Drug Administration (FDA) based on two pivotal, placebo-controlled, double-blind, randomized trials, which established Zavzpret’s safety, tolerability, and efficacy profiles for acute migraine treatment.
In these trials, Zavzpret, a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray, was found to be statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms two hours after the dose.
These results suggest that Zavzpret could provide significant relief for migraine sufferers, who often experience debilitating pain and associated symptoms.
The company plans to launch Zavzpret in pharmacies in July, providing an alternative option for those who prefer nasal spray treatment to oral medication.
This is a significant development, as it expands Pfizer’s migraine portfolio and provides new options for individuals seeking freedom from pain and other symptoms associated with migraines.
The issue of drug pricing is a complex and often controversial topic in the U.S. pharmaceutical industry. When a new drug is launched in the US market, its price is not always immediately known.
This is the case with Pfizer Inc.’s Zavzpret (zavegepant), which recently received FDA approval as the first and only calcitonin gene-related peptide receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.
The pricing of Zavzpret will likely depend on various factors, including the drug’s development and manufacturing costs, the competitive landscape for migraine treatments, and the potential demand for the drug.
Pricing decisions are ultimately made by the drug manufacturer, who must balance the need to recoup their investment in research and development with the need to ensure affordability and accessibility for patients.
Drug pricing has been a contentious issue in the U.S., with many stakeholders, including patients, healthcare providers, and policymakers, expressing concerns about the high cost of prescription medications.
As such, pharmaceutical companies must navigate a complex and often challenging pricing environment when launching new drugs in the U.S. market.
Meanwhile, Pfizer’s has agreed to acquire Seattle cancer specialist Seagen for US$43 billion marks the largest deal in biopharma since AbbVie’s US$63 billion acquisition of Allergan in June of 2019.
The move comes after Pfizer scored two of the three largest M&A deals in biopharma in 2021 and underscores the company’s continued commitment to growth and expansion in the industry.
Seagen is a highly attractive biotech target, with a portfolio of four commercial medicines and a deep pipeline of antibody-drug conjugate (ADC) candidates.
The company reported US$2 billion in revenue last year, a 25% increase from 2021, and Pfizer expects the products brought by Seagen to generate US$10 billion in annual revenues by 2030, with potential for further growth due to the company’s rich pipeline.
The acquisition of Seagen is expected to strengthen Pfizer’s position in the oncology market, which is one of the fastest-growing segments of the pharmaceutical industry.
The deal also reflects Pfizer’s ongoing efforts to diversify its portfolio and expand its presence in high-growth areas of the industry.
