Emgality demonstrated a consistent safety profile across five Phase 3 studies in migraine and episodic cluster headache (N=3262)^1-7

The most frequent adverse reactions with Emgality in the EVOLVE-1, EVOLVE-2, and REGAIN clinical trials were injection site reactions¹

^aInjection site reactions include multiple related adverse event terms, such asinjection site pain, injection site reaction, injection site erythema, and injection sitepruritus.

Review study design for EVOLVE-1 and EVOLVE-2
Review study design for REGAIN

The safety of Emgality was evaluated in >2500 patients with migraine across 3 clinical trials¹

Discontinuation rates

A pooled analysis of 3 clinical trials (EVOLVE-1, EVOLVE-2, and REGAIN) that enrolled 2886 patients showed^7,11:

Hypertension rates were below 1.4% for patients on Emgality 120 mg and placebo, and constipation rates were 1.0% for patients on Emgality 120 mg vs 0.6% for patients on placebo^7,11

Hypertension was reported as a likely cardiovascular treatment-emergent adverse event (TEAE) in¹¹:

Constipation was reported as an adverse reaction in^7,12:

View efficacy for patients with episodic or chronic migraine.

In a 12-month, open-label safety study of patients with episodic or chronic migraine with 4 or more migraine headache days (MHDs) per month,

Treatment-emergent adverse events (TEAEs) were predominantly rated as mild or moderate in severity.¹³

• 54 patients on Emgality 120 mg experienced a TEAE possibly related to study treatment during the 12-month treatment period. The most prevalent TEAEs were injection site pain, injection site reaction, and injection site erythema^6,13
• 6 patients discontinued Emgality 120 mg due to adverse events. 2 patients discontinued due to injection site reaction, 1 patient discontinued due to injection site erythema, and 1 patient discontinued due to lethargy. Other discontinuations due to adverse events were not determined to be related to study treatment^6,13,14
• Of the 54 TEAEs possibly related to study treatment, 27 were deemed mild, 21 were deemed moderate, and 6 were deemed severe¹⁵

See effectiveness and study design for the 12-month, open-label safety study

The safety of Emgality 300 mg was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache^1a

Overall, the safety profile observed in patients with episodic cluster headache treated with Emgality 300 mg monthly was consistent with the safety profile in migraine patients.¹

• 2 patients treated with Emgality discontinued double-blind treatment because of adverse events

^aEmgality Episodic Cluster Headache Study: Emgality 300 mg (N=49), placebo (N=57).

Review Episodic Cluster Headache study design
View efficacy for patients with episodic cluster headache

Immunogenicity¹

As with all therapeutic proteins, there is the potential for immunogenicity. Comparison of the incidence of antibodies to galcanezumab-gnlm with the incidence of antibodies in other studies or to other products may be misleading.

In controlled studies with Emgality up to 6 months (EVOLVE-1, EVOLVE-2, and REGAIN), the incidence of anti-galcanezumab-gnlm antibody development was 4.8% (33/688) in patients receiving Emgality once monthly. With 12 months of treatment in an open-label study, up to 12.5% (16/128) of Emgality-treated patients developed anti-galcanezumab-gnlm antibodies, most of whom tested positive for neutralizing antibodies.

Although anti-galcanezumab-gnlm antibody development was not found to affect the pharmacokinetics, safety, or efficacy of Emgality in these patients, the available data are too limited to make definitive conclusions.

Review study design for EVOLVE-1 and EVOLVE-2
Review study design for REGAIN