- July 1, 2018
- Posted by: PharmaScroll
Eli Lilly and Company announced results from a post-hoc analysis which demonstrated efficacy of Emgality (galcanezumab-gnlm) in patients with episodic and chronic migraine who had previously failed preventive treatment with BOTOX (onabotulinumtoxinA). Detailed results from a post-hoc analysis of three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) were presented as a late-breaking presentation on Saturday, June 30 at the American Headache Society (AHS) annual meeting in San Francisco.
Lilly also announced that the intended brand name, Emgality, has been conditionally accepted by the U.S. Food and Drug Administration (FDA).
Emgality is a once-monthly, self-administered calcitonin gene-related peptide (CGRP) antibody currently under review by the FDA for the prevention of migraine in adults. A decision is expected by the end of September 2018.
“Despite currently available preventive options, nearly half of patients have discontinued these treatments due to side effects or lack of efficacy,” said Christi Shaw, president of Lilly Bio-Medicines. “Over the last two decades, Lilly has recognized and invested in efforts to explore innovative potential treatments for primary headache disorders, including Emgality, which is specifically designed for the prevention of migraine and cluster headache.”
EVOLVE-1, EVOLVE-2 and REGAIN were Phase 3, randomized, double-blind, placebo-controlled studies that evaluated the efficacy of two doses of Emgality (120 mg and 240 mg) in patients with episodic or chronic migraine. This post-hoc analysis evaluated patients treated in the EVOLVE-1 and EVOLVE-2 studies for six months and the REGAIN study for three months. The post-hoc analysis reviewed the mean change from baseline in the number of monthly migraine headache days and the proportion of patients with at least a 50 percent reduction in number of monthly migraine headache days in patients who had previously failed BOTOX due to lack of efficacy or tolerability issues, using integrated EVOLVE-1 and EVOLVE-2 results and REGAIN results.
In this subgroup analysis, patients treated with both doses of Emgality who previously failed preventive treatment with BOTOX experienced a statistically significantly greater reduction in the average number of monthly migraine headache days, and a statistically significantly greater percent (at least a 50 percent) reduction in the number of migraine headache days, compared to patients treated with placebo.
- Average reduction in monthly migraine headache days: 3.91 days for 120 mg and 5.27 days for 240 mg compared to 0.88 days for placebo, p≤0.03 for both dosing groups compared with placebo.
- Mean percentages of patients with at least 50 percent reduction in monthly migraine headache days: 41.3% for 120 mg and 47.5% for 240 mg compared to 9.4% for placebo, p≤0.02 for both dosing groups compared with placebo.
As previously reported in these Phase 3 studies, the most commonly-reported adverse events were injection site reactions.
In this integrated analysis of patients who had previously failed treatment with BOTOX, patients treated with Emgality also had statistically significant improvements in quality of life, as measured by the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Patient Global Impression of Severity (PGI-S) rating.
Emgality represents the first of three investigational, non-opioid treatments in development as part of Lilly’s overall pain portfolio. The portfolio also includes lasmiditan for the acute treatment of migraine and tanezumab, developed in partnership with Pfizer, for the treatment of osteoarthritis pain, chronic low back pain and cancer pain.
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News Source: Eli Lilly website
Image Source: https://www.physiciansweekly.com/galcanezumab-beats-placebo-for-episodic-migraine/