FDA Approves Humanized Monoclonal Antibody For Migraine Treatment.
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults at 27 September of this month.
Migraine is a disabling, neurological disease characterized by recurrent episodes of severe headache accompanied by other symptoms including nausea, vomiting, sensitivity to light and sound, and changes in vision.
Emgality is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and blocks its binding to the receptor. Emgality offers a once-monthly, self-administered, subcutaneous injection.
“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment,” said Christi Shaw, president, Lilly Bio-Medicines. “For more than two 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 efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN).
The recommended dose for Emgality is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.1
Indications and Usage
Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.
Important Safety Information
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Warnings and Precautions
Hypersensitivity reactions (e.g., rash, urticaria and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.
SOURCE: Eli Lilly and Company.