AbbVie’s Aquipta becomes the first oral CGRP migraine drug

introduced to Korea

Aquipta found to reduce the average number of monthly migraine days in 3 trials

Treatment choices expanded, but strict reimbursement criteria remain a challenge...' needs improvement’

Professor Byung-Kun Kim (Department of Neurology, Nowon Eulji Medical Center)

For the first time, an oral CGRP drug has been introduced for the treatment of migraine.

 

AbbVie’s Aquipta has shown positive results as a preventive treatment for chronic migraine as well as episodic migraine in patients who have failed up to 4 prior oral preventive treatments.

 

Experts believe that the benefits of being an oral formulation would allow Aquipta to become a viable new treatment option that can meet the unmet needs of migraine patients in Korea.

 

On the 10th, AbbVie Korea held a press conference to celebrate the launch of Aquipta, its oral calcitonin gene-related peptide (GRRP) receptor agonist, in Korea.

 

Aquipta was approved in Korea last November for migraines in adults.

 

The drug was approved by the U.S.

 

Food and Drug Administration (FDA) in 2021 as a prophylaxis of adult episodic migraine and chronic migraine and in August last year in Europe for the prevention of migraine in adult patients with 4 or more migraine days per month.

 

The domestic approval was based on the Phase III PROGRESS, ADVANCE, and ELEVATE studies.

 

The PROGRESS trial compared the efficacy and safety of Aquipta with placebo in the prevention of chronic migraine.

 

The study enrolled 521 adult patients with a history of chronic migraine (15 or more migraine days per month and at least 8 migraine days per month) for at least 1 year, who were randomized 1:1 to either the Aquipta or placebo arm.

 

The primary endpoint was the change from baseline in the mean migraine days per month during the 12-week treatment period.

 

Results showed a 6.9-day reduction in mean migraine days per month from baseline in the Aquipta arm, compared to 5.1 days in the placebo arm.

 

The ADVANCE trial evaluated the efficacy of Aquipta versus placebo in the prevention of episodic migraine.

 

The study enrolled 458 adult patients with a history of episodic migraine, defined as 4 to 14 migraine days per month.

 

Results showed that the mean number of migraine days per month was reduced by 4.2 days from baseline in the Aquipta arm and 2.5 days in the placebo arm.

 

Also, in the ELEVATE study, which evaluated the prevention of episodic migraine in patients who had failed prior preventive treatments, Aquipta achieved a greater reduction in mean monthly migraine days compared to placebo.

 

Professor Byung-Kun Kim (Department of Neurology, Nowon Eulji Medical Center) said, “The introduction of CGRP receptor antagonists has shown great effect in preventing migraines.

 

However, existing drugs are injectables that require monthly visits to the clinic.

 

So the introduction of an oral option has broadened the pool of treatment options for our patients." “Migraine waxes and wanes over time, so it is very difficult to prove the effectiveness of a new drug over placebo in the area.

 

The fact that Aquipta has demonstrated efficacy in more than 500 patients is meaningful.

 

Clinical trials do not take into account whether migraine patients can conduct their daily lives.

 

With the use of CGRP receptor agonists, we received feedback from patients that they can go about their daily lives.

 

This is an important factor to consider." Migraine severely impacts daily life...' reimbursement standards need to be improved’

Professor Min Kyung Chu (Department of Neurology, Severance Hospital and Chair of the Korean Headache Society)

According to the World Health Organization (WHO), migraine is one of the top 10 conditions that reduce quality of life.

 

According to the 2019 Global Burden of Disease Study, migraine was the second leading cause of disability and the first leading cause of death among women under 50 years of age.

 

In fact, the number of migraine patients is on a constant rise.

 

According to the Health Insurance Review and Assessment Service, the number of migraine patients in Korea increased by 10.5% from 545,607 in 2018 to 602,906 in 2022.

 

While some patients with mild headaches can go about their daily lives, others suffer from symptoms such as nausea, photophobia, phonophobia, and osmophobia.

 

Also, their condition is often accompanied by pain in the eye area, and the migraine attacks may last for more than a day.

 

Professor Min Kyung Chu (Department of Neurology, Severance Hospital) said, “If you have over 3-4 migraine attacks a month, or develop 1-2 migraine attacks a month, you need aggressive preventive treatment.

 

Although costly, CGRP-targeted therapies have changed the landscape of migraine treatment, bringing great benefits to the patients.” Professor Chu added, “Due to strict reimbursement standards set for the use of CGRP treatments in migraines in Korea, more than 90% of the existing CGRP drugs are prescribed without reimbursement.

 

If one drug fails, we need to switch to a different drug, but Korea’s current reimbursement standards do not allow switching between CGRP drugs.

 

Many areas are in need of improvement, and we plan to continue to raise this issue at the academic level as well."