The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) submitted by Eli Lilly for review of its galcanezumab to prevent migraine in adults.
Galcanezumab is a monoclonal antibody being developed to block the activity of calcitonin gene-related peptide (CGRP).
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The BLA seeks use of galcanezumab as a self-administered, once-monthly injection using an auto-injector pen or prefilled syringe.
In its application, the firm included positive results from three Phase III clinical trials, EVOLVE-1, EVOLVE-2 and REGAIN, of galcanezumab in a total of 2,901 subjects.
Results indicated a statistically significant reduction in the average number of monthly migraine headache days with galcanezumab treatment when compared to placebo.
Injection site reactions were the most common adverse events observed during the trials.
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By GlobalDataEli Lilly Bio-Medicines president Christi Shaw said: “Migraine is more than a headache. It is a debilitating disease affecting one in eight Americans and may cause days of lost productivity each month.
“We have worked for more than 25 years to develop innovative migraine therapies, and we are truly pleased to be one step closer to potentially providing a new self-administered and effective preventive treatment option that may help people experience fewer migraine days.”
Galcanezumab is part of the firm’s investigational, non-opioid pain portfolio that includes lasmiditan for acute treatment of migraine and tanezumab for osteoarthritis, chronic low back pain, and cancer pain.
Earlier this month, Lilly obtained approval from the FDA for its Taltz (ixekizumab) 80mg/mL injection to treat adults with active psoriatic arthritis (PsA).
