AbbVie's Atogepant Recommended for EU Approval as First Once-Daily Oral CGRP Receptor Antagonist for Migraine Prevention

Jun 24, 2023 17:30 CST Updated 17:30

AbbVie

Innovative Drug Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

On June 23, AbbVie announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of atogepant for preventive treatment in adult migraine patients experiencing four or more migraine days per month. If approved, atogepant will become the first once-daily oral CGRP receptor antagonist for this condition in the European Union.

Migraine is a complex and common neurological disease, which is clinically characterized by moderate to severe throbbing headache that occurs episodically and is usually unilateral. More than 1 billion people worldwide are affected by migraines, including nearly 11.4% of the population in Europe.

Atogepant is an orally administered CGRP receptor antagonist. CGRP and its receptors are expressed in the nervous system regions associated with the pathophysiology of migraine. Studies have shown that CGRP levels increase during migraine attacks, and selective CGRP receptor antagonists can provide clinical benefits for migraine.

This application is primarily based on data from the Phase III ADVANCE and PROGRESS studies, which evaluated the safety, efficacy, and tolerability of atogepant in patients with episodic migraine and chronic migraine, respectively.

Among them, the ADVANCE clinical trial recruited a total of 910 patients who experienced 4-14 migraine days per month. These patients were randomly assigned to four treatment groups, receiving either 10mg, 30mg, or 60mg of atogepant daily, or a placebo. The results showed that compared with the placebo, all dose groups achieved the primary endpoint, with an average reduction in monthly migraine days of 3.69, 3.86, and 4.2 days, respectively. Additionally, 55.6%, 58.7%, and 60.8% of patients across the increasing dose groups achieved a ≥50% reduction in monthly average migraine days, compared to only 29.0% in the placebo group (p≤0.0001).

The PROGRESS study recruited patients who had been diagnosed with chronic migraine for at least one year and had ≥15 headache days in the 28 days prior to randomization, including 8 migraine days. The primary endpoint of the trial was to evaluate the change from baseline in the average monthly migraine days over the 12-week treatment period for two doses: 60mg (once daily) and 30mg (twice daily). The results showed that both the primary endpoint and all secondary endpoints achieved statistically significant improvement.

In the two Phase III PROGRESS and Phase III ADVANCE studies, all doses were well tolerated, and the overall safety profile was consistent with previous studies in populations for the prevention of episodic migraine and chronic migraine. The most common adverse events were constipation and nausea.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; for republication, please leave a message or send a notification to the WeChat Official Account backend, specifying the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Preview

Online Live Streaming & Offline Salon