Lilly migraine drug Emgality FDA approval : Eli Lilly and Company (Lilly) has bagged approval from the US Food and Drug Administration (FDA) for Emgality (galcanezumab-gnlm) 120 mg injection as a prophylactic therapy for migraine in adults.
Emgality, which is a calcitonin gene-related peptide (CGRP) antagonist, comes with a once-monthly, self-administered, subcutaneous injection. The Lilly migraine drug Emgality should not be used in patients who are seriously allergic to galcanezumab-gnlm or to any of the excipients.
Following the Lilly migraine drug Emgality FDA approval, the US pharma giant is set to launch the new therapy at $575 once-monthly, or $6,900 per year.
Commenting on Emgality FDA approval for the preventive treatment of migraine in adults, Christi Shaw – president, Lilly Bio-Medicines, said: “Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment.
“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.”
According to Lilly, Emgality can be received for free by patients having commercial insurance for up a year as part of the company’s patient support program. The US pharma giant said that Emgality will be available at retail pharmacies shortly for pickup.
Lilly migraine drug Emgality FDA approval is based on the findings of two Phase 3 clinical trials – EVOLVE-1 and EVOLVE-2 in patients with episodic migraine, and also a phase 3 clinical trial – REGAIN in patients with chronic migraine. All the three late-stage trials proved the efficacy and safety of the Lilly migraine drug Emgality.
The recommended dose for Lilly migraine drug Emgality is 240 mg, via two consecutive injections of 120 mg each given subcutaneously once as a loading dose. After which, monthly doses of 120 mg are to be subcutaneously injected in the migraine patients.
Jill Dehlin – chair, Patient Leadership Council, National Headache Foundation, commenting on Lilly migraine drug Emgality FDA approval, said: “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.
“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.”
Video on Lilly migraine Drug Emgality FDA approval
Very recently, the Lilly migraine injection Emgality was given a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the preventive treatment of migraine in adults who experience four or more migraine days a month. The CHMP positive opinion is expected to help in the possible approval of Emgality by the European Commission.