FDA Approves Lilly's Preventive Treatment of Migraine in Adults

Officials with the FDA have approved Eli Lilly’s preventive migraine treatment galcanezumab-gnlm (Emgality), Lilly announced in a press release.

Galcanezumab-gnlm, a once monthly, self-administered 120-mg subcutaneous injection, is indicated for the preventive treatment of migraine headaches in adults. The approval is based on the safety and efficacy data of galcanezumab-gnlm.

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.

“Despite the devastating impact of migraine, only about 10% of people living with the disease are currently taking a preventive treatment,” Christi Shaw, president, Lilly Bio-Medicines, said 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.”

EVOLVE-1 and EVOLVE-2 were both 6-month studies that enrolled adults with episodic migraine, defined as 4 to 14 migraine headache days (MHDs) per month.

EVOLVE-1

• Mean change from baseline (days): -4.7 days (N=210) for galcanezumab-gnlm 120 mg compared with -2.8 days (N=425) for placebo (p<0.001).
• At least a 50% reduction in MHDs in any given month on average (% responders): 62% (N=210) for galcanezumab-gnlm 120 mg compared to 39% (N=425) for placebo (p<0.001).
• 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 (p<0.001).
• One-hundred percent reduction in MHDs in any given month on average (% responders): 16% (N=210) for galcanezumab-gnlm 120 mg compared with 6% (N=425) for placebo (p<0.001).

EVOLVE-2

• Mean change from baseline (days): -4.3 days (N=226) for galcanezumab-gnlm 120 mg compared with -2.3 days (N=450) for placebo (p<0.001)
• At least a 50% reduction in MHDs in any given month on average (% responders): 59% (N=226) for galcanezumab-gnlm 120 mg compared to 36% (N=450) for placebo (p<0.001).
• At least a 75% reduction in MHDs in any given month on average (% responders): 34% (N=226) for galcanezumab-gnlm 120 mg compared with 18% (N=450) for placebo (p<0.001).
• One-hundred percent reduction in MHDs in any given month on average (% responders): 12% (N=226) for galcanezumab-gnlm 120 mg compared with 6% (N=450) for placebo (p<0.001).

REGAIN was a 3-month trial that enrolled adult patients with chronic migraine, defined as at least 15 headache days per month with at least 8 MHDs per month.

• Mean change from baseline (days): -4.8 days (N=273) for galcanezumab-gnlm 120 mg compared with -2.7 days (N=538) for placebo (p<0.001).
• At least a 50% reduction in MHDs in any given month on average (% responders): 28% (N=273) for galcanezumab-gnlm 120 mg compared to 15% (N=538) for placebo (p<0.001).
• Galcanezumab-gnlm 120 mg was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly MHDs over the 3-month treatment period.

Galcanezumab-gnlm was evaluated for safety in 3 clinical trials of more than 2500 patients. 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.

According to the release, galcanezumab-gnlm will be available to patients shortly after approval. Patients with commercial insurance are candidates to receive the treatment for up to 12 months free as part of Lilly’s patient support program.

The FDA also recently approved Teva’s preventive migraine therapy fremanezumab-vfrm (Ajovy). Read more about this approval here.

Reference

Lilly’s Emgality (galcanezumab-gnlm) Receives US FDA Approval for the Preventive Treatment of Migraine in Adults [news release]. Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lillys-emgalitytm-galcanezumab-gnlm-receives-us-fda-approval. Accessed September 28, 2018.