CGRP Archives - Medical Design Sourcing

AbbVie files sNDA with FDA to expand atogepant label

AbbVie (NYSE:ABBV) has submitted a supplemental New Drug Application (sNDA) to the FDA to support the use of atogepant (Qulipta) as a preventive treatment of both episodic and chronic migraine.

FDA approved the drug in September 2021 as a preventive treatment of episodic migraine in adults.

In March 2022, AbbVie announced that the Phase 3 PROGRESS study testing atogepant met its primary endpoint of reducing mean monthly migraine days over placebo in patients with chronic migraine.

In its recent sNDA filing, AbbVie included data from the pivotal Phase 3 PROGRESS trial in patients with chronic migraine. The placebo-controlled study met its primary endpoint, which related to a statistically significant reduction from baseline in mean migraine days per month.

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) developed as a preventive migraine therapy.

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Pfizer to shell out $11.6B for migraine drugmaker Biohaven

Pfizer (NYSE:PFE) today announced that it has entered into an agreement to acquire Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), which is best known for Nurtec ODT (rimegepant), a dual-acting migraine therapy.

Pfizer will pay $148.50 per share in cash to acquire Biohaven, totaling approximately $11.6 billion.

Nurtec generated $462 million in revenue in 2021. Pfizer anticipates that the acquisition will fuel continued growth through the remainder of the decade and beyond.

Evaluate Pharma projects that Nurtec could generate $2 billion in international sales by 2026.

Nurtec image courtesy of Biohaven

Nurtec is a calcitonin gene-related peptide (CGRP) agonist that has emerged as a popular preventive treatment for migraines with or without aura.

Notable competitors in the class include Qulipta (atogepant) from AbbVie (NYSE:ABBV and Ubrelvy (ubrogepant) from AbbVie subsidiar…

AbbVie’s migraine drug Qulipta wins FDA nod as a preventive migraine treatment

Qulipta (atogepant) from AbbVie (NYSE:ABBV) has become the first calcitonin gene-related peptide (CGRP) agonist to win FDA approval for the preventive treatment of migraine headaches.

In recent years, the agency has approved two related drugs, Ubrelvy (ubrogepant) from AbbVie subsidiary Allergan (NYSE:ABBV) and Nurtec ODT (rimegepant sulfate) from Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN). Both of those products are indicated for the acute treatment of migraines with or without aura.

North Chicago–based AbbVie published results from the pivotal ADVANCE study in The New England Journal of Medicine.

Qulipta bottle image courtesy of AbbVie

Participants in the trial had a mean number of monthly migraine days ranging from 7.5 to 7.9. Recipients of 10-mg atogepant saw an average reduction of 3.7 days in migraine days per month. For the sake of comparison, recipients of 30-mg atogepant …

A neurologist dishes on the migraine treatment landscape

Migraine image courtesy of Pixabay

Migraines are a prevalent condition, affecting about one billion people across the world. “In the U.S., about 13% of the population experiences migraine headaches regularly,” said Dr. Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago.

In the following interview, Feoktistov shed light on the prevalence of the condition and shares his thoughts on the overall treatment landscape. A forthcoming article will touch on how migraine treatments have evolved over the past two decades, focusing on the impact of recently introduced therapies.

Could you briefly summarize how you diagnose migraines?

Feoktistov: Migraine headaches typically start in childhood or during adolescence and frequently continue throughout most of the patient’s life. We sometimes see outliers when people start experiencing headaches later …