Eli Lilly and Company (NYSE: LLY) announced results of the CHALLENGE-MIG clinical trial of Emgality® (galcanezumab-gnlm) and Nurtec® ODT (rimegepant orally disintegrating tablet), the first and only trial of its kind comparing two calcitonin gene-related peptide (CGRP) antagonist therapies.
| Emgality demonstrated robust efficacy for patients consistent with previous studies, although it did not achieve statistical superiority versus active comparator on the primary endpoint Emgality performed numerically better than the active comparator on key secondary endpoints of the CHALLENGE-MIG trial The CHALLENGE-MIG study demonstrates Lilly’s commitment to migraine research and results underscore that people living with episodic migraine deserve broad access to effective treatments INDIANAPOLIS, June 16, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results of the CHALLENGE-MIG clinical trial of Emgality® (galcanezumab-gnlm) and Nurtec® ODT (rimegepant orally disintegrating tablet), the first and only trial of its kind comparing two calcitonin gene-related peptide (CGRP) antagonist therapies. Emgality did not meet the study’s primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. Response rates were similar. However, it demonstrated clinically meaningful efficacy and safety in this 3-month study consistent with Emgality’s previous 6-month studies. And, Emgality performed numerically better on key secondary endpoints of the 3-month trial. “These results bolster our knowledge of Emgality’s ability to work quickly and help patients improve their quality of life with less frequent dosing,” said Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience. “Reducing the frequency of migraine headache days can help people experience more freedom from the burden of this debilitating neurological disease and get back to participating in the daily activities that matter most to them.” Emgality is a monoclonal antibody (mAb) that inhibits the effects of CGRP by binding directly to CGRP, while gepants like Nurtec ODT bind to and block the CGRP receptor. Emgality is administered via injection, and Nurtec ODT is administered orally. CHALLENGE-MIG was a 3-month, double-blind clinical study that assessed the efficacy and safety of Emgality compared to Nurtec ODT in the prevention of episodic migraine in adults. The study randomized 580 participants to either four injections of Emgality 120 mg (a loading dose of two injections followed by two additional monthly injections) or 45 doses of Nurtec ODT 75 mg (one oral tablet every other day), both of which are the regulatory approved doses. Also, patients assigned to Emgality received placebo ODT and patients assigned to Nurtec ODT received placebo injections. “Despite being the third most common disease worldwide, migraine remains largely under-diagnosed and under-treated,” said Peter Goadsby, MBBS, M.D., Ph.D., King’s College London and University of California, Los Angeles, CA. “I applaud Lilly for embarking on this bold study and their continued investment in the migraine community to better inform care. These results reinforce the impact that innovative medicines can have in the prevention of migraine.” In CHALLENGE-MIG, the safety profiles of Emgality and Nurtec ODT were consistent with those previously reported for both treatments. There were no new safety findings. Lilly will disclose the full results of the CHALLENGE-MIG trial later this year. About Emgality Indications and Usage for Emgality (galcanezumab-gnlm) 120 mg/300 mg Injection
Important Safety Information for Emgality (galcanezumab-gnlm) Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the post marketing setting. Cases of anaphylaxis and angioedema have also been reported in the post marketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged. The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions. For more information about Emgality, please see Full Prescribing Information. See Instructions for Use included with the device. GZ HCP ISI 14SEP2022 About Lilly Lilly Forward-Looking Statement All product/company names shown herein are the trademarks of their respective owners.
SOURCE Eli Lilly and Company | ||||||
Company Codes: NYSE:LLY |
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