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Designing a brand new therapy to deal with migraine successfully

8 min read
Designing a brand new therapy to deal with migraine successfully

On this interview, we converse 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 function at AbbVie?

My title 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 non-public household physician-owned apply. As my profession progressed, I needed to take my love of serving to sufferers to an even bigger scale and transitioned to a task 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 function at AbbVie, I lead a worldwide staff 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 world unmet medical want akin to Alzheimer’s illness.

At present, AbbVie is engaged on a brand new therapy choice for migraine. With 1 billion individuals 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 may forestall individuals from performing every day actions. Not solely is it a extremely prevalent situation, but it surely’s additionally the main reason for incapacity worldwide for individuals underneath 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 completely different sufferers in a different way, with some individuals residing with frequent and extra extreme migraine. Since not all therapies work for everybody, now greater than ever, it is very important introduce new and completely different choices, particularly for these sufferers who expertise extra frequent and extreme migraine.

Designing a brand new therapy to deal with migraine successfully

Picture Credit score: peterschreiber.media/Shutterstock.com

As migraine is a posh neurological illness, how does this make discovering efficient therapies tougher? What elements should be thought-about when designing a brand new therapy?

No two migraine sufferers are alike. That is what makes discovering therapy choices tougher. The important thing to understanding migraine, and thus maintaining in thoughts new therapies, is that the dysfunction is way more than only a headache. It could embrace quite a lot of different signs – vomiting, nausea, and sensitivity to gentle, to call a number of. Due to this, many sufferers are compelled to hunt further therapy choices from physicians because of the problem of discovering ample reduction. It is necessary for physicians to have the ability to acknowledge the migraine spectrum and prescribe correct therapy.

What does the present therapy panorama for episodic and continual migraine seem like? How do these two forms of migraine differ?  

Migraine is characterised broadly by assault frequency. Folks residing with episodic migraine usually have one to 14 headache days per thirty days. Folks with continual migraine expertise 15 or extra headache days every month, with migraine signs on not 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 authorization utility for the preventative therapy of each episodic and continual migraine in adults. BOTOX (onabotulinumtoxinA) is accredited for the preventive therapy for grownup sufferers with continual migraine globally, and ubrogepant has been accredited for the acute (quick) therapy of migraine with or with out aura within the U.S.

AbbVie has lately submitted a Advertising and marketing Authorization Utility (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 every day oral CGRP receptor antagonist (gepant) for the prophylaxis therapy of migraine in Europe.

Migraine Therapy

Picture Credit score: Juan Gaertner/Shutterstock.com

AbbVie’s utility is predicated on the Section 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 up to now?

The advertising authorization utility (MAA) submission to the European Medicines Company (EMA) for atogepant for the prophylaxis of migraine in grownup sufferers is predicated on two pivotal Section 3 research evaluating atogepant in grownup sufferers with episodic and continual migraine: the ADVANCE trial and PROGRESS examine.

The pivotal, Section 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial evaluated the efficacy, security, and tolerability of as soon as every day (QD) oral atogepant for the prophylaxis of episodic migraine. The examine met its main 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 Issues (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 not 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, Section 3, world, randomized, double-blind, placebo-controlled, parallel-group PROGRESS examine, evaluating the protection, efficacy, and tolerability of oral atogepant in grownup sufferers for the prophylaxis of continual migraine, met its main 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 every day (QD) and 30 mg every 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 not less than a 50 % discount in imply month-to-month migraine days throughout the 12-week therapy interval.

In each the Section 3 PROGRESS and Section 3 ADVANCE research, all doses had been properly tolerated, and the general security profiles had been in keeping with security findings noticed in earlier research for the prophylaxis of episodic migraine and continual migraine populations. The most typical adversarial occasions had been constipation and nausea.

If profitable, AbbVie could be the one firm to supply two therapies for people with continual migraine. How important is that this throughout the subject of pharmaceutical analysis?

If accredited, not solely would AbbVie be the one firm to supply two therapies for individuals affected by continual migraine, however atogepant would even be the primary every day oral CGRP receptor antagonist (gepant) for the preventative therapy of migraine in Europe.

Whereas continual migraine impacts just one%-2% of the worldwide inhabitants, individuals 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 continual or episodic migraine.

Do you consider that atogepant might revolutionize the way in which migraine is at the moment 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 individuals affected by migraine and finally assist sufferers scale back the variety of days they undergo from migraine every month. At AbbVie, we attempt to empower individuals residing with migraine illness and to offer them with the most effective probability of migraine freedom.    

Are you hopeful that with continued analysis, funding, and collaboration throughout the drug discovery sector, we’ll proceed to additional perceive the pathophysiology of neurological and psychiatric issues?

Completely. It is a actually thrilling time to work in neuroscience analysis because 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 gasoline us to dive deeper and proceed advancing science in pursuit of latest 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 issues is unwavering.

Investing in Innovation

What’s subsequent for AbbVie and migraine analysis?

At AbbVie, we proceed to struggle alongside sufferers, care companions, and clinicians towards migraine’s often-unrelenting burden. By way of schooling, ongoing cutting-edge analysis and improvement, and partnerships with the migraine neighborhood, we attempt to assist these with migraine navigate obstacles to care, entry efficient therapies and scale 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 worldwide staff 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 world unmet medical want akin to Alzheimer’s illness.Mudra Kapoor

My profession started as a main care doctor. As my profession progressed, I started to be taught extra and do extra, inspiring me to transition to AbbVie as an Affiliate Medical Director within the Doctor Growth program gaining foundational expertise in analysis and improvement. Whereas in that function, I executed tasks throughout rheumatology, metabolics, and hepatology.
From there, my function broadened to incorporate Hepatitis C Scientific Growth. 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 one in all our Associates turned the very best performing globally. My function expanded to incorporate a number of different therapeutic areas such and main my staff throughout a number of initiatives together with sturdy proof era and scientific communication. Subsequently I returned to the US and led the Rheumatology International Medical Affairs staff to make sure we enabled profitable launches throughout rheumatolgy indications globally.
A revered chief in medical affairs, I’ve obtained 9 awards from AbbVie in recognition for exemplifying integrity, equity, and honesty in my work, and have revealed 15 peer-reviewed articles.

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