On this interview, we communicate to Mudra Kapoor, M.D., Vice President of International Medical Affairs for Neuroscience at AbbVie, about therapy choices for migraine and the affect for victims worldwide.
Please are you able to introduce your self and inform us about your position at AbbVie?
My identify is Mudra Kapoor, and I am the Vice President of International Medical Affairs for Neuroscience at AbbVie. By coaching, I began my profession as a accomplice at a personal household physician-owned observe. As my profession progressed, I needed to take my love of serving to sufferers to an even bigger scale and transitioned to a job at AbbVie, the place I gained foundational analysis and improvement expertise. This permits me to broaden my affect on sufferers in methods I couldn’t earlier than.
In my present position at AbbVie, I lead a world workforce offering medical management, strategic planning, resourcing, and scientific oversight for AbbVie’s mixed neuro-portfolio for a number of illness areas, together with Parkinson’s illness, migraine, therapeutic neurotoxin indications together with, post-stroke spasticity & cervical dystonia and the promising neuroscience pipeline addressing ailments with important international unmet medical want comparable to Alzheimer’s illness.
At present, AbbVie is engaged on a brand new therapy choice for migraine. With 1 billion folks worldwide affected by migraine, why are new therapy choices wanted now greater than ever?
Migraine is a posh neurological illness that may considerably have an effect on the standard of life. Recurrent migraine assaults are sometimes incapacitating and might forestall folks from performing day by day actions. Not solely is it a extremely prevalent situation, however it’s additionally the main reason behind incapacity worldwide for folks beneath 50 years of age. This poses each a social and monetary burden that may negatively affect household life, social life, and work life.
Migraine impacts totally different sufferers in another way, with some folks residing with frequent and extra extreme migraine. Since not all remedies work for everybody, now greater than ever, you will need to introduce new and totally different choices, particularly for these sufferers who expertise extra frequent and extreme migraine.
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As migraine is a posh neurological illness, how does this make discovering efficient remedies more difficult? What elements must be thought of when designing a brand new therapy?
No two migraine sufferers are alike. That is what makes discovering therapy choices more difficult. The important thing to understanding migraine, and thus preserving in thoughts new remedies, is that the dysfunction is way more than only a headache. It might probably embrace quite a lot of different signs – vomiting, nausea, and sensitivity to mild, to call just a few. Due to this, many sufferers are compelled to hunt further therapy choices from physicians as a result of problem of discovering sufficient aid. It is essential for physicians to have the ability to acknowledge the migraine spectrum and prescribe correct therapy.
What does the present therapy panorama for episodic and persistent migraine appear like? How do these two varieties of migraine differ?
Migraine is characterised broadly by assault frequency. Folks residing with episodic migraine typically have one to 14 headache days per 30 days. Folks with persistent migraine expertise 15 or extra headache days every month, with migraine signs on no less than eight of these days, every lasting 4 or extra hours.
From an AbbVie pipeline perspective, atogepant has been accredited by the U.S. FDA for the preventive therapy of episodic migraine in adults and is awaiting EMA approval of its’ advertising and marketing authorization software for the preventative therapy of each episodic and persistent migraine in adults. BOTOX (onabotulinumtoxinA) is accredited for the preventive therapy for grownup sufferers with persistent migraine globally, and ubrogepant has been accredited for the acute (rapid) therapy of migraine with or with out aura within the U.S.
AbbVie has just lately submitted a Advertising Authorization Software (MAA) to the European Medicines Company (EMA) for atogepant within the preventive therapy of migraine. Please are you able to inform us extra about how atogepant was designed and the way it works to successfully deal with migraine?
Atogepant is an orally administered CGRP receptor antagonist (gepant) particularly developed for the prophylaxis (preventative) therapy of migraine. CGRP and its receptors are expressed in areas of the nervous system related to migraine pathophysiology. Research have proven that CGRP ranges are elevated throughout migraine assaults, and selective CGRP receptor antagonists confer scientific advantages in migraine.
If accredited, atogepant could be the primary day by day oral CGRP receptor antagonist (gepant) for the prophylaxis therapy of migraine in Europe.
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AbbVie’s software relies on the Part 3 ADVANCE and PROGRESS research evaluating atogepant’s efficacy for migraine, amongst different elements. Are you able to inform us extra about these research and the outcomes to this point?
The advertising and marketing authorization software (MAA) submission to the European Medicines Company (EMA) for atogepant for the prophylaxis of migraine in grownup sufferers relies on two pivotal Part 3 research evaluating atogepant in grownup sufferers with episodic and persistent migraine: the ADVANCE trial and PROGRESS examine.
The pivotal, Part 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial evaluated the efficacy, security, and tolerability of as soon as day by day (QD) oral atogepant for the prophylaxis of episodic migraine. The examine met its major endpoint of a statistically important discount in imply month-to-month migraine days throughout the 12-week therapy interval in comparison with placebo. This was discovered throughout all energetic therapy arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses. The grownup sufferers enrolled met the Worldwide Classification of Headache Problems (ICHD) standards for a prognosis of migraine with or with out aura. The examine additionally discovered {that a} higher proportion of atogepant-treated members achieved no less than a 50% discount in imply month-to-month migraine days for all doses in comparison with placebo and met different key secondary endpoints.
The pivotal, Part 3, international, randomized, double-blind, placebo-controlled, parallel-group PROGRESS examine, evaluating the security, efficacy, and tolerability of oral atogepant in grownup sufferers for the prophylaxis of persistent migraine, met its major endpoint of statistically important discount from baseline in imply month-to-month migraine days in comparison with placebo throughout the 12-week therapy interval. The trial additionally demonstrated that therapy with atogepant 60 mg as soon as day by day (QD) and 30 mg day by day (BID) resulted in statistically important enhancements in all secondary endpoints. This features a key secondary endpoint that measured the proportion of sufferers that achieved no less than a 50 p.c discount in imply month-to-month migraine days throughout the 12-week therapy interval.
In each the Part 3 PROGRESS and Part 3 ADVANCE research, all doses have been effectively tolerated, and the general security profiles have been in line with security findings noticed in earlier research for the prophylaxis of episodic migraine and persistent migraine populations. The most typical hostile occasions have been constipation and nausea.
If profitable, AbbVie could be the one firm to supply two remedies for people with persistent migraine. How important is that this inside the area of pharmaceutical analysis?
If accredited, not solely would AbbVie be the one firm to supply two remedies for folks affected by persistent migraine, however atogepant would even be the primary day by day oral CGRP receptor antagonist (gepant) for the preventative therapy of migraine in Europe.
Whereas persistent migraine impacts just one%-2% of the worldwide inhabitants, folks residing with frequent, extra extreme migraine have the best want for therapy and obtain 50% of preventive migraine prescriptions. Atogepant has the potential to offer a preventative therapy choice for grownup sufferers affected by persistent or episodic migraine.
Do you imagine that atogepant might revolutionize the best way migraine is at present handled? What would this imply not solely to scientific settings however for the sufferers themselves additionally?
If accredited, atogepant would add one other therapy choice for folks affected by migraine and in the end assist sufferers cut back the variety of days they endure from migraine every month. At AbbVie, we try to empower folks residing with migraine illness and to offer them with the very best likelihood of migraine freedom.
Are you hopeful that with continued analysis, funding, and collaboration inside the drug discovery sector, we are going to proceed to additional perceive the pathophysiology of neurological and psychiatric problems?
Completely. It is a actually thrilling time to work in neuroscience analysis as a consequence of speedy developments in precision medication, knowledge convergence, and genetics/genomics, that are fueling information throughout the business.
That is to not say neuroscience is not difficult. Setbacks are inevitable, however setbacks are what gas us to dive deeper and proceed advancing science in pursuit of recent therapies. Each problem on this uncharted territory drives us to find options for sufferers, care companions, and clinicians. Our dedication to preserving personhood for these residing with neurological and psychiatric problems is unwavering.
Investing in Innovation
What’s subsequent for AbbVie and migraine analysis?
At AbbVie, we proceed to battle alongside sufferers, care companions, and clinicians in opposition to migraine’s often-unrelenting burden. By training, ongoing cutting-edge analysis and improvement, and partnerships with the migraine group, we try to assist these with migraine navigate limitations to care, entry efficient remedies and cut back the affect of migraine on their lives.
The place can readers discover extra data?
About Mudra Kapoor, MD
As VP Neuroscience, International Medical Affairs, I lead a world workforce offering medical management, strategic planning, resourcing, and scientific oversight for AbbVie’s mixed neuro-portfolio for a number of illness areas, together with Parkinson’s illness, migraine, therapeutic neurotoxin indications together with post-stroke spasticity & cervical dystonia and the promising neuroscience pipeline addressing ailments with important international unmet medical want comparable to Alzheimer’s illness.
My profession started as a major care doctor. As my profession progressed, I started to study extra and do extra, inspiring me to transition to AbbVie as an Affiliate Medical Director within the Doctor Improvement program gaining foundational expertise in analysis and improvement. Whereas in that position, I executed tasks throughout rheumatology, metabolics, and hepatology.
From there, my position broadened to incorporate Hepatitis C Scientific Improvement. I then superior to Medical Director of Mature Merchandise, the place I developed and led the strategic initiatives for merchandise throughout the life cycle, spanning metabolic, immunology, anti-infective, pulmonary, and ache therapeutics.
The following step in my profession journey introduced me to Singapore, the place I ensured launch readiness for 2 hepatology merchandise throughout the Asia Pacific area, the place certainly one of our Associates grew to become the best performing globally. My position expanded to incorporate a number of different therapeutic areas such and main my workforce throughout a number of initiatives together with strong proof era and scientific communication. Subsequently I returned to the US and led the Rheumatology International Medical Affairs workforce to make sure we enabled profitable launches throughout rheumatolgy indications globally.
A revered chief in medical affairs, I’ve acquired 9 awards from AbbVie in recognition for exemplifying integrity, equity, and honesty in my work, and have printed 15 peer-reviewed articles.
