Lilly Launches Head-to-Head Trial in Quest to Bolster Migraine Preventive Drug
Eli Lilly and Company announced Tuesday the launch of a head-to-head study to compare once-monthly injectable Emgality® (galcanezumab-gnlm) with Nurtec® ODT (rimegepant) for the prevention of migraine.
Emgality, a monoclonal antibody, selectively binds to calcitonin gene-related peptide (CGRP). The U.S. Food and Drug Administration approved the therapy in 2018 for the preventive treatment of migraine. Real-world data presented at the American Headache Society (AHS) 2021 Virtual Annual Scientific Meeting in June show greater patient adherence and persistence for the drug than the oral standard of care in patients with migraines.
Nurtec is an orally disintegrating tablet that is taken by patients every other day. In contrast to Emgality, Nurtec blocks the receptor for CGRP rather than binding to the protein.
In the multi-site, randomized Phased IV study, researchers will enroll patients with episodic migraine with or without aura. One treatment arm will study a once-monthly injection of Emgality 120 mg with an initial 240 mg loading dose, while the other arm will assess Nurtec ODT 75 mg taken every other day. Both arms will be compared in terms of the primary endpoint – a 50% reduction in monthly migraine headache days.
According to board member of the National Headache Foundation and managing director of the Diamond Headache Clinic and longstanding, Dr. Merle Diamond, patients with migraines have increasingly asked for easy and convenient treatments to improve productivity and free up time away from constant medication dosing. “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,” said Dr. Diamond in a statement.
“Providing patients with options and individualized treatment plans is vitally important,” said senior vice president and president of Lilly Bio-Medicines, Ilya Yuffa. “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.”
Yuffa added that the company has been able to help more than 700,000 patients with Emgality this year alone. The company will begin enrolling patients in the study later this year to better understand the treatment and its effects on migraine and patient-centered outcomes.
The news of the study was announced an escalating legal battle between Ajovy drug maker Teva Pharmaceuticals and Eli Lilly. On Tuesday, the Israeli drug maker filed a new suit against Eli Lilly, claiming the latter’s Emgality infringes on two newly granted patents for Ajovy. In the suit, Teva hopes to prevent Eli Lilly from manufacturing and selling the CGRP inhibitor therapy in the U.S. The company is also claiming damages in the form of financial compensation.
This suit is nothing new; Teva sued Eli Lilly after Emgality’s approval in 2018 over an alleged infringement on up to nine patents for Ajovy.