FDA Greenlights Galcanezumab (Emgality) for Migraine Prevention
US Food and Drug Administration (FDA) has approved the calcitonin gene–related peptide (CGRP) antagonist galcanezumab-gnlm (Emgality, Eli Lilly and Co) for the prevention of migraine in adult patients, the manufacturer reports. This marks the agency's third approval this year of an anti-CGRP for this indication, following earlier approvals of erenumab(Aimovig, Amgen and Novartis) and fremanezumab-vfrm (Ajovy, Teva). The humanized monoclonal antibody also received recommended marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use last week. The FDA's approval is for a 120-mg self-administered, subcutaneous injection of galcanezumab. The recommended dose is 240 mg once as a loading dose, administered in two consecutive injections of 120 mg each, followed by monthly injections at 120 mg. It is contraindicated in patients with "serious hypersensitivity" to the drug or to any of its excipients, notes the company in a press release. It adds that the injectable drug will be available to patients "shortly after approval." "I have lived with migraine for more than 30 years and I have experienced firsthand the impact it has on your life, including the ability to perform daily activities," Jill Dehlin, chair of the Patient Leadership Council of the National Headache Foundation, said in the same release. "Those of us living with migraine have spent years hoping for new treatment options, and I am thankful for the efforts by researchers, investigators, and clinical trial patients who have helped make this possible," Dehlin added
