FDA Approves Galcanezumab for Migraine Prevention

Galcanezumab will be available as a monthly 120 mg injection in pen and syringe forms for the prevention of migraine in adults.

The US Food and Drug Administration (FDA) approved galcanezumab (Emgality) for the preventive treatment of migraine in adults. The 120 mg dose is offered as a once-monthly, self-administered, subcutaneous injection in either pen or syringe forms.

"Despite the devastating impact of migraine, only about 10% of people living with the disease are currently taking a preventive treatment," said Christi Shaw, president, Lilly Bio-Medicines, in a statement. "For more than 2 decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease."

The FDA’s approval decision was based in part on efficacy and safety data from a pair of phase 3 trials—ELVOLVE-1 and EVOLVE-2—in patients with episodic migraine and one—REGAIN—in patients with chronic migraine.

EVOLVE-1 and EVOLVE-2 were conducted over six-month periods with participants with episodic migraine. Participants were randomized to galcanezumab 120 mg, 240 mg, or placebo. In EVOLVE-1, participants responded with an average reduction of 4.7 days for 120 mg and 4.6 days of 240 mg compared to an average reduction of 2.8 days for placebo, P <.001 for both dosing groups. In EVOLVE-2, the average reduction was 4.3 days for 120 mg and 4.2 days for 240 mg compared to an average reduction of 2.3 days for placebo, P <.001 for both dosing groups.

The REGAIN trial of patients with chronic migraine was conducted over a three-month study period in 1113 participants. Participants experienced a significant reduction in average monthly migraine headache days: 4.8 days for 120 mg and 4.6 days for 240 mg, compared to an average reduction of 2.7 days for placebo, P <.001 for both dosing groups.

Galcanezumab also demonstrated a significant reduction in monthly migraine days for patients with treatment-resistant migraine, defined as those who had previously failed ≥2 preventative treatments. Participants with treatment-resistant migraine accounted for 9.8% of EVOLVE participants (n=172) and 29.5% of REGAIN (n=323) participants.

Due to a much lower placebo effect among study participants with treatment-resistant migraine, the galcanezumab treatment arm was especially successful. In the EVOLVE studies, percentages of patients with at least a 50% reduction in monthly migraine headache days were placebo: 26.2%, galcanezumab 120mg: 54.6%, and galcanezumab 240mg: 61.2%. In REGAIN, the results were placebo: 9.7%, GMB_120mg: 30.4%, and GMB_240mg: 18.3%.

The galcanezumab Prescribing Information lists a recommended dosage of 240 mg (two 120 mg injections) as an initial loading dose, followed by monthly 120 mg subcutaneous injections. Either the pen or syringe forms may be injected in the abdomen, thigh, back of the upper arm, or buttocks.

The most common adverse effects (occurring ≥2% and at least 2% greater than in placebo) were injection site reactions. These reactions occurred in 18% of clinical trial patients receiving galcanezumab, compared to 13% of those receiving placebo. Hypersensitivity reactions, such as rash, urticaria, and dyspnea, have also occurred.