Patients will be randomized to either 120-mg galcanezumab or 75-mg rimegepant and will be evaluated on the percentage of patients achieving a 50% reduction in monthly migraine headache days.
Eli Lilly recently announced a phase 4 study comparing its once-monthly injectable galcanezumab (Emgality), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), to Biohaven’s rimegepant (Nurtec ODT), an orally disintegrating CGRP receptor antagonist. Enrollment for the study is expected to begin later this year.1
Galcanezumab binds to the GCRP protein, preventing it from attaching to the CGRP receptors, whereas rimegepant blocks the receptor for this protein. The study, which is the first head-to-head clinical trial comparing 2 medications targeting CGRP, will aim to answer important questions that will help clinicians and patients make more informed treatment decisions, according to Eli Lilly.
The multisite, randomized, double-blind, double-dummy, parallel-group study will use 50% reduction in monthly migraine headache days as the primary end point. Patients with a diagnosis of episodic migraine with or without aura will be treated with either 120-mg galcanezumab once-monthly injection with an initial 240-mg loading dose, or 75-mg rimegepant taken every other day.
"Migraine is a painful, burdensome and complex neurologic disease. Every person’s experience is different. Providing patients with options and individualized treatment plans is vitally important,” Ilya Yuffa, senior vice president and president, Lilly BioMedicines, said in a statement. “We are confident in Emgality’s efficacy profile and that our head-to-head clinical trial against Nurtec ODT will yield valuable insights for patients and their healthcare providers.”
The FDA approved galcanezumab in September 2018 for the preventive treatment of migraine in adults. To date, it is the only CGRP mAb that includes response rates of at least 50%, at least 75%, and 100% reduction in monthly migraine headache days in patients with episodic migraine in its FDA-approved labeling. Rimegepant, meanwhile, was originally approved in a 75-mg dose for the acute treatment of migraine in February 2020, then adding to its prior indication in May 2021 by becoming the first approved medication for both acute and preventive therapy.2
Since both of these approvals, each drug has had a number of research assessments conducted to further confirm their efficacy and safety, with some of these data included in abstracts presented at the recent 2021 American Headache Society (AHS) 63rd Scientific Annual Meeting, June 3-6. One such dataset included real-world insights from a healthcare claims study that showed greater adherence and persistence for galcanezumab compared to oral standard of care for migraine prevention with a non-CGRP mAb.3 Additionally, post-hoc data from 4 clinical trials of galcanezumab found no differences between dose groups of galcanezumab or placebo in rates of “wearing off” effect.4
"The American Headache Society and the National Headache Foundation have endorsed several goals that raise the treatment outcomes bar for preventive migraine medications. Patients tell us they want an easy and convenient migraine treatment that can help them be productive and free to focus on what matters most to them. In order for patients to manage their own disease and have a sense of personal control, they need to find treatments that work for them that they can stay on. Reducing the number of days patients experience migraine is possible and it's important that patients and their HCPs talk about this as a goal," Merle Diamond, managing director, Diamond Headache Clinic, and longstanding board member, National Headache Foundation, said in a statement.1
"Undertaking this head-to-head study signals Lilly's confidence in Emgality, a once-monthly injectable monoclonal antibody CGRP, as it compares to Nurtec ODT, a small molecule oral CGRP receptor antagonist (gepant), for the prevention of migraine,” she added. Diamond previously shared her insight on the real-world use of these new migraine medicines with NeurologyLive in an episode of the Mind Moments podcast. She discussed her experience with the agents and their impact on clinical practice, as well as the most promising therapies in the pipeline.
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