Migraine, reimbursement ok for preventive oral therapy in adults

(Adnkronos) – AbbVie announces reimbursement approval for atogepant for the treatment of adults experiencing at least 8 days of disabling migraine per month in the past 3 months. This approval – reports a note – makes atogepant the first oral calcitonin gene-related peptide (CGRP) receptor antagonist reimbursed for the preventive treatment of episodic and chronic migraine, at the recommended dose of 60 mg once daily (quam die , Qd). ‘Episodic migraine’ refers to migraine sufferers who have fewer than 15 headache days per month; migraine is defined as chronic in those who report 15 or more headache days per month, of which at least 8 are migraine.

“Migraine is the second most disabling disease in the world, affecting more than 1 billion people, of which 6 million in Italy alone, with a prevalence 3 times higher in women. Chronic migraine, in particular, affects 1-2% of the global population – says Alessandro Padovani, director of the Neurological Clinic of the University of Brescia and president of the Italian Society of Neurology (Sin). The World Health Organization (WHO) considers a day spent with migraine to be disabling, comparable to a condition of dementia, quadriplegia or acute psychosis, and this data is even more significant if we take into account the fact that migraine often occurs manifests itself in the age group between 20 and 50 years, at the time of life when people are most active and productive”.

The indication of atogepant in migraine prophylaxis – we read – is supported by the results of 2 pivotal phase 3 studies, Advance and Progress, which evaluated the efficacy and safety of atogepant 60 mg Qd in adult patients, respectively affected from episodic and chronic migraine during a 12-week treatment period. In both randomized placebo-controlled studies, atogepant was effective, with a good safety profile and well tolerated and also capable of determining an improvement in the patients’ health-related quality of life.

This optimal efficacy and safety/tolerability profile – the note details – was also confirmed in a population of patients with episodic migraine that were difficult to treat, or with a history of therapeutic failure with 2-4 classes of oral drugs for migraine prophylaxis. , in the 12-week randomized, placebo-controlled Elevate study. Furthermore, the efficacy of atogepant 60 mg Qd was maintained for up to one year in a long-term open-label study, where 48% of patients with episodic migraine reported a 100% reduction in migraine days per day. month (i.e. freedom from migraine or ‘migraine freedom’) in the last month of treatment.

“We still have unmet clinical needs in the treatment of migraine. Many patients suffering from episodic or chronic migraine do not achieve optimal control of the disease despite taking one or more preventive treatments – explains Cristina Tassorelli, professor of Neurology at the University of Pavia and director of the Headache Research Center of the Mondino Institute – Atogepant is the first, and currently the only, oral therapy for the prevention of the entire migraine spectrum specifically designed to block the effect of CGRP; it is a simple to use, effective therapy, with a good safety profile and well tolerated. The evidence coming from clinical studies tells us that with atogepant we have a preventive therapeutic option available capable of reducing the impact of the pathology on people’s lives”.

“Having a correct diagnosis makes the difference in the management of the disease, yet even today many patients take years before receiving the most appropriate therapy for their pathology – declares Fabrizio Greco, CEO of AbbVie Italia – Our company has long been involved in the field of neuroscience to develop therapeutic solutions that can make a difference in the lives of patients depending on their treatment needs. With the approval of atogepant, our neuroscience portfolio expands, establishing ourselves as a point of reference in the treatment of migraine, and we will work together with patient associations, scientific societies, institutions and treatment centers to ensure that all patients can access to this innovative therapy throughout the national territory”.