Eli Lilly Initiates Head-to-Head CHALLENGE-MIG Trial Comparing Emgality and Nurtec ODT for Preventive Treatment of Episodic Migraine
Nov 23, 2021 01:36
CST Updated
01:36
Eli Lilly
Global Pharmaceutical R&D and Production Company
November 22, 2021 /BioValleyBIOON/ --Eli Lilly(Eli Lilly) recently announced, CHALLENGE-MIGClinical TrialPatient enrollment has begun.This is the first and only head-to-head trial comparing two anti-calcitonin gene-related peptide (CGRP) drugs for the preventive treatment of episodic migraine (EM) in adults.. The study is expected to enroll approximately 700 adults with episodic migraine in the United States and willComparison between Emgality (galcanezumab-gnlm, once-monthly subcutaneous injection) and Nurtec® ODT (rimegepant, orally disintegrating tablet, taken every other day), and adopt patient-centered indicators, including reducing the number of migraine days per month and improving quality of life.
Calcitonin Gene-Related Peptide (CGRP) is a protein in the brain that is believed to play a key role in migraines. While both Nurtec ODT and Emgality target CGRP, their mechanisms of action differ: Emgality is a monoclonal antibody (mAb) that binds to CGRP, whereas Nurtec ODT works by binding to and blocking the CGRP receptor.
The CHALLENGE-MIG study, which has been initiated this time, aims to deepen the understanding of the role of CGRP monoclonal antibodies (mAb) in the preventive treatment of migraine and answer some important questions to help doctors and patients make informed treatment decisions.
Shivang Joshi, a neurologist at the Dent Neurologic Institute in New York and an investigator for the CHALLENGE-MIG study, stated: "Migraines can significantly impact daily activities, depriving people of their everyday lives and special occasions. Reducing the frequency of migraine attacks can help people gain more migraine-free days and enjoy a higher quality of life; both are essential treatment goals."Eli LillyThe CHALLENGE-MIG study will help us understand how different types of preventive treatment drugs (CGRP monoclonal antibodies and gepants) help people achieve the most important goals for them. Excitingly, the insights generated from this first-of-its-kind head-to-head trial will be able to inspire discussions between migraine patients and their healthcare providers regarding treatment plans.
Migraine is the third most common disease and the sixth most disabling disease globally. It is a common chronic neurovascular disorder characterized by recurrent severe headaches, often unilateral. It is estimated that the total number of migraine patients worldwide exceeds 1 billion, with approximately 90% experiencing episodic migraine (EM), which is characterized by up to 14 migraine days per month. The remaining 10% suffer from chronic migraine (CM), which involves headaches on at least 15 days per month, with 8 or more days featuring migraines, and the condition persists for over 3 months. Currently, there is no medication that can cure migraines. The World Health Organization (WHO) has listed migraines as one of the top 10 most disabling diseases. Compared to other populations, migraine patients are more likely to experience depression, anxiety, sleep disorders, other pain conditions, and fatigue.
Calcitonin Gene-Related Peptide (CGRP) is a neuropeptide that has been shown to be released during migraine attacks and is considered a trigger for migraine episodes. Currently, CGRP and its receptor have become popular targets for migraine drug development.
As of now, four monoclonal antibody therapies targeting CGRP and its receptor for migraine have been launched, including:Eli LillyEmgality (targeting CGRP), Amgen/NovartisAimovig (targeting CGRP receptor), Lundbeck's Vyepti (targeting CGRP), Teva's Ajovy (targeting CGRP). In terms of administration, both Emgality and Aimovig are administered via subcutaneous injection once a month, Ajovy can be injected subcutaneously once a month or once every three months, and Vyepti is administered intravenously once every three months.
Among them, Emgality was approved by the U.S. FDA in September 2018 for the preventive treatment of migraine in adults. In June 2019, Emgality received another approval in the United States.FDAApproved for the treatment of episodic cluster headache (ECH) in adults. Notably,Emgality is the first drug to treat ECH and also the first CGRP antibody that can treat two different headache disorders.
Nurtec ODT, developed by Biohaven, was approved in February 2020 for the acute treatment of migraine (with or without aura) in adults, regardless of the number of migraine days per month. In May 2021, Nurtec ODT received approval for a new indication: preventive treatment of migraine, specifically for adult patients with episodic migraine (EM) who experience fewer than 15 headache days per month.
It is worth mentioning that,Nurtec ODT is the first oral CGRP antagonist approved for the preventive treatment of migraine, and also the first migraine drug approved for both acute treatment and preventive treatment.. (Bioon.com)
