FDA Approves Another Expensive Migraine Drug - Pain News Network

By Pat Anson, PNN editor

The highly competitive and lucrative migraine drug market will get even tighter this month when AbbVie launches Qulipta (Atogepant), an oral CGRP drug designed for the preventative treatment of episodic migraines.

The Food and Drug Administration approved Qulipta after seeing the results of a Phase 3 clinical trial that found the drug was 50 to 100% effective in reducing the number of monthly migraine days.

“During the study, I had much fewer migraine days while taking Qulipta. For the first time, I have no difficulties with my daily activities and I don’t have to worry so much about missing important events with family and friends during a migraine attack,” said Kelsi Owens, a study participant who has lived with migraines for nearly three decades.

Like other CGRP inhibitors, Qulipta blocks proteins, called peptides related to the calcitonin gene, from attaching to nerve receptors in the brain and causing migraine pain. As of 2018, the FDA has approved over half a dozen CGRP drugs, most of which are injected monthly.

Qulipta is a tablet to be taken daily and comes in three different dosages. Like other CGRP inhibitors, Qulipta is expensive. The wholesale price for a patient without insurance is $ 991 for 30 pills, according to Abbvie. Insured patients or patients participating in an AbbVie patient support program pay less.

“Qulipta offers a simple oral treatment option specifically designed to prevent migraine attacks and combat CGRP, which is believed to be critical to migraine headaches in many patients,” said study researcher Peter Goadsby, MD, neurologist and professor from the University of California, Los Angeles. “I am particularly encouraged by the convenience of daily oral use of Qulipta, its rapid onset of significant efficacy, its safety and tolerability, and its high patient response rates.”

Qulipta is expected to compete with Nurtec, an oral CGRP drug from Biohaven Pharmaceuticals that is approved for both the prevention and treatment of migraines. A delivery of eight Nurtec tablets costs around 941 US dollars, depending on the insurance coverage. Since its introduction in 2020, Nurtec has generated sales of around $ 200 million for Biohaven and filled out over 750,000 recipes.

AbbVie expects Qulipta to be available in early October. Side effects of Qulipta include nausea, constipation, fatigue, and loss of appetite. The company is currently conducting a clinical trial to see if Qulipta should also be approved for the prevention of chronic migraines – patients who have 15 or more headaches a month.

According to the American Migraine Foundation, migraines affect more than 37 million people in the United States. In addition to headaches, migraines can cause nausea, visual disturbances and sensitivity to light and noise. Women are three times more likely to have migraines than men.