Galcanezumab-gnlm, is a once monthly, self-administered 120-mg subcutaneous injection, indicated for the preventive treatment of migraine headaches in adults.
Trade name Emgality.
The treatment was evaluated in patients with episodic migraine in 2 phase 3 trials (EVOLVE-1 and EVOLVE-2) and in patients with chronic migraine in another phase 3 trial (REGAIN).
In all 3 studies, patients received once-monthly placebo, galcanezumab-gnlm, 120 mg after an initial loading dose of 240 mg, or galcanezumab-gnlm 240 mg.
EVOLVE-1 and EVOLVE-2 were both 6-month studies that enrolled adults with episodic migraine, defined as 4 to 14 migraine headache days per month.
EVOLVE-1 Mean change from baseline (days): -4.7 days for galcanezumab-gnlm 120 mg compared with -2.8 days for placebo.
At least a 50% reduction in migraine headache days in any given month on average (% responders): 62% for galcanezumab-gnlm 120 mg compared to 39% for placebo.
At least a 75% reduction in MHDs in any given month on average (% responders): 39% (N=210) for galcanezumab-gnlm 120 mg compared with 19% (N=425) for placebo.
The most commonly reported adverse reactions were injection site reactions.
The recommended dose for galcanezumab-gnlm is 240 mg, 2 consecutive subcutaneous injections of 120 mg each, once as a loading dose and followed by monthly doses of 120 mg injected subcutaneously.