AbbVie said the European Medicines Agency’s Committee on Medicinal Products for Human Use (EMA) had adopted a positive opinion recommending approval of atogepant for migraine prophylaxis in adults who have four or more migraine days per month.
If approved, AbbVie will be the only company to offer once daily oral calcitonin gene linked peptide (CGRP) receptor antagonist (gepant) treatment covering episodic and chronic migraine in the European Union (EU).
Chronic migraine (CM) is characterized by 15 or more headache days a month and at least eight migraine days, while episodic migraine (EM) refers to people with migraines who have fewer than 15 headache days per month. In Europe, migraines are estimated to cost the economy €50 billion ($54.4 billion) each year due to reduced productivity and lost work days.
“Migraine is a complex neurological disease and one of the leading causes of disability worldwide, which is why we are continuously advancing our science to provide effective treatment options for people living with this debilitating condition,” said Dawn Carlson, vice president, development neuroscience, AbbVie.
“The recent positive CHMP opinion on atogepant brings us closer to providing a new therapeutic option for those living with migraine in the European Union.”
CHMP’s positive opinion of atogepant is supported by data from two important phase 3 studies, PROGRESS and ADVANCE, which evaluated atogepant 60 mg once daily (QD) in adult patients with chronic and episodic migraine. Both studies achieved their primary endpoint of a statistically significant reduction in mean monthly migraine days (MMDs), compared with placebo over a 12-week treatment period. Moreover, statistically significant improvement was seen in all secondary endpoints with atogepant 60 mg QD.
In the PROGRESS study, the change from baseline on MMD was -6.8 days for atogepant 60 mg QD and -5.1 days for placebo. In the ADVANCE study, the change from baseline on MMD was -4.1 days for atogepant 60 mg QD and -2.5 days for placebo. In both studies, atogepant 60 mg QD was well tolerated and the most common side effects were constipation, nausea, and fatigue. The most frequent adverse drug reaction leading to study termination was nausea (0.4%).
“Too many people around the world are affected by migraines, and the course of treatment can be long and complicated,” said Patricia Pozo-Rosich, chief of neurology, Vall d’Hebron Hospital and Research Institute, Spain.
“The approval of atogepant would represent a meaningful advance for the migraine community in the European Union, providing adults with four or more migraine days per month a new prophylactic treatment option that offers the possibility of ongoing migraine prevention.”
Migraines are very common, affecting 1 billion people worldwide, including about 41 million people in Europe. Individuals with migraines often experience migraine attacks that are disabling, prevent them from carrying out their daily activities and significantly affect their quality of life. This debilitating disease places a social and financial burden on both people living with migraines and the health care system.
Atogepant is an orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraines in adults who have four or more migraine days per month. CGRP and its receptors are expressed in areas of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels increase during a migraine attack and that selective CGRP receptor antagonists confer clinical benefit in migraine.
Other companies take a different approach to dealing with migraines. US-biotech Vaxxinity aims to democratize medicine by developing affordable vaccines for chronic conditions like migraine, Alzheimer’s, and Parkinson’s – to name a few. By combining the power of mAbs and the ease and affordability of vaccines, Vaxxinity’s synthetic peptide platform aims to provide highly effective drugs for all.