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Amgen/Novartis Move Successful Endpoint Results of Erenumab to First Migraine Preventive Approval in US

May 21, 2018
FDA has approved the CGRP inhibitor for prophylactic migraine in adults

with Lawrence Robbins, MD, and representatives from Amgen/Novartis

Calcitonin gene-related peptide (CGRP) is a vasoactive peptide that makes up part of the “inflammatory soup” involved in the dilation of cerebral and dural blood vessels. Widely distributed throughout the body, CGRP levels in serum increase during migraine or cluster headache, and four biopharmaceutical companies have developed antagonists specifically designed to block CGRP, and thus, prevent migraine. Over the past few years, the healthcare and financial communities have kept their eyes and ears pinpointed on these companies, as one by one, they began to file biologic license applications (BLAs) with the US Food and Drug Administration. Late on May 17, 2018, Amgen Inc. announced that it has obtained the first approval, marking a new frontier in migraine prevention and management.

Amgen developed erenumab (AMG334, Aimovig) in collaboration with Novartis. The receptor antagonist has a 28-day half-life and is administered monthly at-home via a single-use autoinjector for the prevention of migraine in adults.

Like its competitors, erenumab is a large molecule monoclonal antibody (mAb) that works both indirectly, by activating host immune systems, and directly by binding to ligands or receptors. This new class of medication has very little potential for drug-drug interactions because it is metabolized through the reticuloendothelial system, explains Lawrence Robbins, MD, director of the Robbins Headache Clinic in Riverwoods, Illinois. Dr. Robbins is also a member of PPM’s Editorial Advisory Board.

Next in line for regulatory approval of their migraine preventives are:

  • Teva Pharmaceuticals’ fremanezumab - the company has filed a BLA and anticipates FDA action by Q3 or Q4 of this year. (Read about Teva’s recently released Phase 3 trial results.) 
  • Eli Lilly and Company’s galcanezumab - the company has filed a BLA (Read about Lilly’s recently released Phase 3 trial results.) 
  • Alder Pharmaceuticals’ eptinezumab  - FDA is expected to review the company’s application in 2019.

In addition, a few small molecule developers are working on oral formulations of CGRP inhibitors, referred to as the gepant class, which are metabolized through the liver. These include Biohaven Pharma’s rimegepant/BHV-3000 for acute migraine and BHV-3500 for migraine prevention, and Allergan’s ubrogepant for acute migraine and atogepant for migraine prevention.

Specifically designed to prevent migraine by blocking the CGRP receptor, Aimovig is the result of a decade-long neuroscience research and development effort using Amgen’s 35-plus years of experience—particularly in antibodies technology, Amgen Scientific Director Cen Xu told Practical Pain Management. “This long-awaited novel treatment option for 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 will offer a new chance at relief for patients living with migraine disease.”

Results of Amgen/Novartis’ pivotal Phase 3 STRIVE study of patients with episodic migraine were published in the New England Journal of Medicine. Trial participants 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, Marcia Kayath, MD, PhD, MBA, a senior vice president and the US Clinical Development and Medical Affairs Head at Novartis, told Practical Pain Management. 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, she added.

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 percent of patients receiving placebo.

In the upcoming June 2018 issue of Practical Pain Management, representatives of Amgen/Novartis and the additional CGRP game-changers recap their trial data to date and share their perspective on the progress being made in migraine prevention. In addition, our Fall 2018 Special Edition will provide PCPs and pain practitioners with a practical guide to assessing and managing the wide spectrum of chronic headache and migraine.

Last updated on: May 21, 2018
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