FDA Accepts BLA for Galcanezumab for Migraine Prevention

DECEMBER 11, 2017
Jenna Payesko
Galcanezumab, FDA, Biologics License Application, migraineEli Lilly and Company has announced the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) to review galcanezumab for the prevention of adults with migraine.

The application includes positive data from 3 phase 3 studies EVOLVE-1, EVOLVE-2 and REGAIN that evaluated the safety and efficacy of 2 doses of galcanezumab administered subcutaneously, 120 mg or 240 mg once-monthly, following a 240 mg starting dose.

"Galcanezumab represents the first of 3 investigational, non-opioid treatments in development as part of Lilly's overall pain portfolio," Wei-Li Shao, vice president, US Lilly Neurosciences, told MD Magazine. "Across our phase 3 studies of galcanezumab, patients experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to placebo, which translates to more migraine-free days for these patients. This is significant for patients who have not yet tried, or found, an effective treatment, and we are thrilled to bring a new era of innovative migraine therapies to market."
 
In the trials, which evaluated 2,901 patients, those treated with galcanezumab experienced a statistically greater decrease in the average number of monthly migraine headache days compared to the placebo.

Galcanezumab has been submitted for use as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe.

The most commonly-reported adverse effects were injection site reactions, including pain.

In both the EVOLVE-1 and EVOLVE-2 studies, patients with episodic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a significant decrease in the average number of monthly migraine headache days versus those treated with the placebo throughout the 6-month treatment period. Significant improvements were observed at each month starting a 1 month of treatment.

In EVOLVE-1, a significant percentage of patients treated with both doses achieved at least a 50%, 75% and 100% reduction in the number of migraine headache days compared to placebo throughout the treatment period: patients that experienced at least a 50% reduction: 62.3% for the 120-mg dose and 60.9% for the 240-mg dose versus 38.6% for placebo; patients that experienced at least a 75% reduction: 38.8% for the 120-mg dose and 38.5% for the 240-mg dose versus 19.3% for placebo; and patients that experienced a 100% reduction: 15.6% for the 120-mg dose and 14.6% for the 240-mg dose versus 6.2% for placebo.

In EVOLVE-2, a significant percentage of patients also treated with both doses achieved at least a 50%, 75% and 100% reduction in the number of migraine headache days compared to placebo throughout the treatment period: patients that experienced at least a 50% reduction: 59.3% for the 120-mg dose and 56.5% for the 240-mg dose versus 36% for placebo; patients that experienced at least a 75% reduction: 33.5% for the 120-mg dose and 34.3% for the 240-mg dose versus 17.8% for placebo; and patients that experienced a 100% reduction: 11.5% for the 120-mg dose and 13.8% for the 240-mg dose versus 5.7% for placebo.

Patients treated with galcanezumab in both of the EVOLVE studies experienced a greater reduction of monthly migraine headaches with acute medication use compared to those treated with placebo.

An improvement was also demonstrated in physical function compared to placebo, as measured by both the Role Function-Restrictive (RF-R) domain score of the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Patient Global Impression of Severity (PGI-S) rating after multiplicity adjustment.

Throughout a 3-month treatment period, patients with chronic migraine in the REGAIN study treated with galcanezumab 120 mg and 240 mg doses experienced a statistically greater decrease in the average number of monthly migraine headache days versus placebo.

A greater percentage of patients also achieved at least a 50% reduction in the number of migraine headache days versus placebo throughout the treatment period (27.6% for the 120-mg dose and 27.5% for the 240-mg dose versus 15.4% for placebo).

Compared with placebo, patients treated with the 240-mg dose of galcanezumab achieved at least a 75% reduction in the number of migraine headache days (8.8% versus 4.5% for placebo) after multiplicity adjustment, and achieved a greater reduction in the number of monthly migraine headache days with acute medication use (an average of 4.3 days compared to 2.2 days for placebo). 

Patients treated with 240 mg saw a significant improvement in physical function, as measured by the RF-R domain score of the MSQ and PGI-S rating after multiplicity adjustment.

“For many people, the impact of migraine can be all-encompassing — a person may miss work, family activities or social engagements," Shao added. "Of the approximately 40% of all patients with migraine who are eligible for preventive therapy, only 13% are currently taking preventive medications. As such, millions of patients suffering from migraine are losing at least 1 month per year to migraine."

Galcanezumab was further evaluated in REGAIN for an additional 9 months of an open-label extension phase following the 3-month phase.

The monoclonal antibody is specifically designed to bind to and inhibit the activity of calcitonin gene-related peptide and is under evaluation for the prevention of migraine and cluster headache.

A press release was made available.

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