osed for 12 months.
In placebo-controlled clinical studies (Studies 1, 2, and 3), 705 patients received at least one dose of EMGALITY 120 mgonce monthly, and 1451 patients received placebo, during 3 months or 6 months of double-blind treatment [see ClinicalStudies (14)]. Of the EMGALITY-treated patients, approximately 85% were female, 77% were white, and the mean agewas 41 years at study entry.
The most common adverse reaction was injection site reactions. In Studies 1, 2, and 3, 1.8% of patients discontinueddouble-blind treatment because of adverse events. Table 1 summarizes the adverse reactions that occurred within up to 6months of treatment in the migraine studies.
Table 1: Adverse Reactions Occurring in Adults with Migraine with an Incidence of at least 2% for EMGALITY andat least 2% Greater than Placebo (up to 6 Months of Treatment) in Studies 1, 2, and 3
Adverse Reaction
EMGALITY 120 mg
Monthly
(N=705)
Placebo
Monthly
(N=1451)
% %
Injection site reactionsa 18 13
a Injection site reactions include multiple related adverse event terms, such as injection site pain, injection site reaction,injection site erythema, and injection site pruritus.
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highlydependent on the sensitivity and specificity ofthe assay. Additionally, the observed incidence of antibody (includingneutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, samplehandling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, comparison of the incidence of antibodies to galcanezumab-gnlm in the studies described below withthe incidence of antibodies in other studies or to other products may be misleading.
The immunogenicity of EMGALITY has been eva luated using an in vitro immunoassay for the detection of binding anti galcanezumab-gnlm antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro ligandbindingimmunoassay was performed to detect neutralizing antibodies.
In controlled studies with EMGALITY up to 6 months (Study 1, Study 2, and Study 3), the incidence of anti-galcanezumabgnlmantibody development was 4.8% (33/688) in patients receiving EMGALITY once monthly (32 out of 33 of whom hadin vitro neutralizing activity). With 12 months of treatment in an open-label study, up to 12.5% (16/128) of EMGALITYtreatedpatients 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.USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women.
Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout
pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on
development (see Animal Data).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies is 2% - 4% and 15% - 20%, respect |
