It will be especially female people who will benefit from the new pharmacological treatment with preventive action on forms of episodic and chronic migraineof which she was recently refundability approved by the National Health Service.
Atogepant, this is the name of the molecule, is indicated for the treatment of adults who experience at least 8 days of disabling migraine per month in the last three months. And it is therefore the first oral calcitonin gene-related peptide (CGRP) receptor antagonist reimbursed for the preventive treatment of episodic and chronic migraineat the recommended dose of 60 mg once daily.
Migraine, a disabling disease
Migraine is the second most disabling disease in the worldaffects more than 1 billion people, of which 6 million in Italy alonewith a prevalence three times higher in women.
It is defined as «episodic» when you have them less than 15 days of headache per monthwe speak instead of «chronic migraine» when they are reported 15 or more headache days per month of which at least 8 were migraine.
“In its chronic form, migraines affect 1-2% of the global population,” he explains 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 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, it manifests itself in the age group between 20 and 50 yearsat the time of life when people are most active and productive.”
Having a correct diagnosis makes the difference in managing the disease, yet today many patients still take years before receiving the most appropriate therapy for their pathology. However, with the arrival of the gepant class and with the approval and reimbursement of atogepant – which can be administered upon prescription by a specialist doctor – the scenario is enriched with new preventive treatments capable of reducing the burden of disease and the impact on everyday life.
“People living with migraines may have frequent disabling attacks that prevent them from carrying out daily, personal and work activities, significantly affecting their quality of life,” he says Alessandra Sorrentino, President of the Alleanza Cafalalgici Association (Al.Ce) of the CIRNA Onlus Foundation. «In recent years we have witnessed a therapeutic paradigm shift in the management of migraine. As an Association, we will work to ensure that all therapeutic options, especially the most innovative ones, are accessible in any region of Italy, continuing to support patients in overcoming stigma in society, in a path that improves awareness of the pathology.”
How effective is the new drug
The action of atogepant on migraine is supported by the results of two studies that evaluated its efficacy and safety in adult patients suffering from episodic and chronic migraine respectively 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 was also confirmed in a population of difficult-to-treat episodic migraine patients, i.e. with a history of therapeutic failure with 2-4 classes of oral drugs for migraine prophylaxis.
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 month (i.e. freedom from migraines 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”, he clarifies 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 life of people.”
