The 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. Phase 3 Trials As reported at the time by Medscape Medical News, detailed results from three phase 3 trials that assessed galcanezumab were presented at the 2017 American Headache Society Annual Scientific Meeting. In EVOLVE-1 and EVOLVE-2, which together included more than 1700 patients with episodic migraine, the participants who received 120 or 240 mg of the active drug experienced significantly greater reductions in monthly migraine headache days than those who received matching placebo. Similar results were shown in the REGAIN trial, which included more than 1100 patients with chronic migraine. Adverse events reported in the three studies included injection site pain, reactions, and erythema. The company reports that the US list price for the drug will be $575 once monthly or $6900 annually. However, "patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program," said the manufacturer. "Despite the devastating impact of migraine, only about 10% of people living with the disease are currently taking preventive treatment," Christi Shaw, president of Lilly Bio-Medicines, said in the release. "With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease," she added. Source
