The first and only oral CGRP receptor antagonist approved in the U.S. for preventing both episodic and chronic migraines in adults. The Phase 3 study of Qulipta (atogepant) demonstrated significantly reduced monthly migraine days compared to placebo over a 12-week period.

The following article originally appeared in BioSpace.

AbbVie on Friday released interim Phase III data for its calcitonin gene-related peptide receptor blocker Qulipta (atogepant), which demonstrated long-term safety and efficacy for patients in preventing chronic and episodic migraine.

After 13 to 16 weeks of follow-up, 70% of the treated patients saw at least a 50% drop in the number of monthly migraine days. On average, monthly migraine days improved by 8.5 days at this time point. These benefits on migraine frequency were consistent throughout 48 weeks of open-label treatment, according to AbbVie.

In terms of safety, Qulipta showed no new signals of concern over the long-term follow up, and its adverse event profile was consistent with what had been established in prior trials. The most common side effects were COVID-19, nasopharyngitis and constipation.

“Patients should accept nothing less than migraine freedom, and the long-term safety and efficacy shown in this interim analysis marks another step toward that goal,” Dawn Carlson, vice president of neuroscience development at AbbVie, said in a statement.

The pharma is working toward additional regulatory filings for Qulipta in various international markets.

Friday’s interim data come from an ongoing Phase III study, dubbed 3101-312-002, which is an open-label, 156-week extension study in nearly 600 patients. Efficacy was measured using eDiary entries at weeks 13 to 16, 29 to 32 and 45 to 48.

Designed to be orally available, Qulipta is a small molecule drug that works by blocking the calcitonin gene-related peptide (CGRP) receptor, which is believed to play an important role in migraine by dilating cerebral blood vessels and promoting the release of inflammatory mediators. The CGRP receptor can also make peripheral and central neurons more sensitive to pain transmission.

Qulipta’s mechanism of action allows it to disrupt these pathologic signaling cascades. The drug won the FDA’s approval in September 2021 for the prevention of episodic migraine.

Friday’s readout comes as the UK’s National Institute for Health Care and Excellence (NICE) on Thursday signed off on using Qulipta to prevent migraine in adult patients who suffer from at least four migraine days per month. Under NICE’s draft guidance document, Qulipta can only be used after at least three preventive treatments have failed. Qulipta should be discontinued if, after 12 weeks of treatment, episodic migraines do not drop by 50% or chronic migraines are not reduced by 30%, according to the agency.

AbbVie has also entered into a commercial agreement with the UK’s National Health Service, agreeing to provide Qulipta at an undisclosed discount.

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