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12 Articles in Volume 18, Issue #4
A New Frontier in Migraine Management: Inside CGRP Inhibitors & Migraine Prevention
Assessment of Patients with Rheumatoid Arthritis or Osteoarthritis
Biosimilars in Rheumatology: How Popular Will They Be?
Case Studies in Regenerative Cellular Therapy: Tendinopathy and Osteoarthritis
Commentary: Make the Easy Choice for Care
Editorial: The Emergence of Trackable Pill Technology: Hype or Hope?
Editorial: The Practicality of Pain Acceptance
How to Avert Government Scrutiny When Prescribing Opioids
Letters to the Editor: DEA and Prescribing, the War on Statistics, Failing Treatments, Patients' Options
Meet the Migraine Game-Changers
Platelet-Rich Plasma and Stem Cell-Rich Prolotherapy for Musculoskeletal Pain
With concerns over opioids, could novel receptors be useful?

Meet the Migraine Game-Changers

Amgen/Novartis, Allergan, Lilly, and Teva recap the data that is moving their CGRP migraine preventives to the finish line.
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In  this exclusive roundtable, Amgen/Novartis, Allergan, Lilly, and Teva recap the data that is moving their CGRP migraine preventives to the finish line.

Introduction to CGRPs by Lawrence Robbins, MD

 

Amgen/Novartis

HQ: Thousand Oaks, CA and Basel, Switzerland
Product: erenumab-aaoe (Aimovig, preventive)
Status: FDA approved Aimovig in May 2018 for the prevention of migraine in adults.

Perspective by Cen Xu, PhD
Scientific Director, Amgen

Patients endure and manage around migraine disease. As such, people with migraine may feel as though time has been taken from them, or constantly live in anticipation of the next migraine attack. Compounding this effect, many migraine patients may not find the relief they need with existing treatment options, or cannot tolerant them.1

Aimovig is a newly approved agent specifically designed to prevent migraine by blocking the receptor of the calcitonin gene-related peptide (CGRP), which plays a key role in migraine pathophysiology. It is the result of a decade-long neuroscience research and development effort using Amgen’s 35-plus years of experience—particularly in antibodies technology. We are applying this expertise in entering into the neuroscience space to treat some of the most debilitating diseases, as part of our mission to serve patients.

Aimovig was approved by the FDA in May 2018 for the preventive treatment of migraine in adults. Aimovig is administered once monthly using Amgen’s SureClick autoinjector, a single-use autoinjector. Monthly self-injection offers patients the ability to administer their medication from home, while still under the regular supervision of their care provider

Aimovig brings a long-awaited novel, treatment option to patients living with a disease that has been largely misunderstood and plagued with significant gaps in the way it is both perceived by the public and treated in the clinic. Amgen, and our collaborator Novartis, hope this will offer excitement and a new chance of relief for patients living with this disease.

Perspective by Marcia Kayath, MD, PhD, MBA
Senior Vice President, US Clinical Development & Medical Affairs Head, Novartis

Over the course of clinical research and development, Aimovig was studied in several large global, randomized, double-
blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 3,000 patients participated in the Aimovig clinical program across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.

In the pivotal Phase 3 STRIVE study in patients with episodic migraine, patients taking Aimovig experienced a significant reduction in monthly migraine days versus placebo and were significantly more likely to achieve a 50% or greater reduction in monthly migraine days than those taking placebo. The results of this study reinforced existing evidence for the consistent benefits of Aimovig demonstrated across the spectrum of chronic and episodic migraine, including patients who failed on previous preventive treatments.2

In the STRIVE study, adverse events occurring in greater than 5% of all treatment arms were nasopharyngitis and upper respiratory tract infection. More than 90% of patients in the Aimovig-treated arms completed the six-month study. Adverse events leading to discontinuation of treatment occurred in 2.2% of patients in either Aimovig treatment arm and in 2.5% of patients receiving placebo.

People living with migraine are missing out on many daily activities due to this debilitating neurological disease, and are in need of additional preventive treatment options. Together with Amgen, Novartis is committed to bringing this much-needed treatment option to patients as soon as possible. As a leader in neuroscience for more than 70 years, we are dedicated to partnering with patients and doctors in an effort to change the lives of people impacted by neurological conditions, and it is our hope that Aimovig will help patients get back more days from migraine.

Allergan

HQ: Dublin, Ireland
In the Pipeline: ubrogepant (acute); atogepant (preventive)
Status: Ubrogepant NDA to be filed in 2019; atogepant Phase IIb topline results expected in 2018.

Perspective by David Nicholson,
Chief Research and Development Officer

While acute and preventive treatment options currently exist, of the 30 million migraine patients in the United States, less than one third – or an estimated 8 million people – are treated with a prescription medication.3-5 Clearly, there are patients who are underserved, underdiagnosed, and undertreated. Allergan, which has been studying migraine for more than 20 years, continues to work toward advancing the science behind migraine.

The new category of CGRP receptor antagonists may offer an opportunity in the treatment of migraine. Allergan has four investigational oral CGRP trials for ubrogepant (acute treatment of migraine attack) and one for atogepant (preventive treatment of migraine) running in the US, where safety and efficacy have yet to be established. CGRP receptor antagonists may provide additional acute and preventive treatment options through a new mechanism of action for treating migraine. CGRP receptors have been localized to many areas of the central nervous system (CNS) that are involved in the pathophysiology of migraine, with studies suggesting that serum CGRP levels elevate during migraine attacks.6,7

Two pivotal Phase 3 trials for ubrogepant, ACHIEVE I and ACHIEVE II, demonstrated positive topline results in efficacy, safety, and tolerability; results were released earlier this year. ACHIEVE I included 1,327 US adult patients randomized to placebo, ubrogepant 50mg, or ubrogepant 100mg, who were treated for a single migraine attack of moderate-to-severe headache intensity. The study met co-primary endpoints. Both doses showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at 2 hours after initial dose compared to placebo patients (50 mg vs placebo, p = 0.0023; 100 mg vs placebo, p = 0.0003) and a statistically significant greater percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptoms at 2 hours after the initial dose compared to placebo patients (50 mg vs placebo, p = 0.0023; 100 mg vs placebo, p = 0.0023).

Last updated on: June 20, 2018
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Migraine Treatment Set for Reboot
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