11.09 – Monday 21 October 2024
(The following text is taken entirely from the press note sent to the Opinion Agency) –
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A new therapeutic option to prevent migraines. AbbVie announces reimbursement approval for atogepant.
– <a href="http://www.world-today-news.com/migraine-reimbursement-ok-for-preventive-oral-therapy-in-adults/” title=”Migraine, reimbursement ok for preventive oral therapy in adults”>Atogepant is the first oral therapy reimbursed in Italy for the preventive treatment of migraine in adults who experience at least 8 days of disabling migraine per month1
– The indication of atogepant in the prevention of migraine is supported by two pivotal phase 3 studies which demonstrate how the molecule leads to a statistically significant reduction, compared to the baseline period, in terms of migraine days per month in adult patients suffering of episodic migraine or chronic migraine compared to those treated with placebo2,3
– The portfolio of migraine therapies that AbbVie makes available to adult patients in Italy is expanding.
AbbVie announces reimbursement approval for atogepant for the treatment of adults experiencing at least 8 days of disabling migraine per month in the past three months1.
This approval 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 day, 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.4
“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 three times higher in women5. Chronic migraine, in particular, affects 1-2% of the global population6 – states Prof. 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 occurs in the age group between 20 and 50, at the time of life when people are most active and productive”.
The indication of atogepant in migraine prophylaxis is supported by the results of two pivotal phase 3 studies, ADVANCE and PROGRESS, which evaluated the efficacy and safety of atogepant 60 mg QD in adult patients, respectively suffering from episodic migraine and chronic 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’ quality of life related to their health status2,3.
This optimal efficacy and safety/tolerability profile was also confirmed in a population of patients with difficult-to-treat episodic migraine, i.e. with a history of therapeutic failure with 2-4 classes of oral drugs for migraine prophylaxis, in the ELEVATE study, randomized placebo-controlled trial lasting 12 weeks7.
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 treatment8.
“We still have unmet clinical needs in the treatment of migraine. Many patients with episodic or chronic migraine do not achieve optimal disease control despite taking one or more preventative treatments. Atogepant is the first, and currently only, oral migraine prevention therapy specifically designed to block the effect of CGRP; it is a therapy that is simple to use, effective, with a good safety profile and well tolerated – explains Prof. Cristina Tassorelli, Professor of Neurology at the University of Pavia and Director of the Headache Research Center of the Mondino Institute. 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”.
“People living with migraine may have frequent disabling attacks that prevent them from carrying out daily, personal and work activities, significantly affecting their quality of life9. In recent years we have witnessed a therapeutic paradigm shift in the management of migraine. With the arrival of the gepant class and with the approval and reimbursement of atogepant, the scenario is enriched with new preventive treatments capable of reducing the burden of the disease and the impact on daily life – states Alessandra Sorrentino, President of the Alleanza Association Cafalalgici (Al.Ce) of the CIRNA Onlus Foundation. 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 the stigma in society, in a path that improves awareness of the pathology”.
“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 Eng. Fabrizio Greco, CEO of AbbVie Italia. Our Company has long been engaged 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.”
