The FDA has approved a new drug called Emgality (galcanezumab) for adults. It is used to prevent migraines and to treat episodic cluster headaches. Emgality is a monthly injection that you give yourself. It works by blocking a protein in the brain that is linked to pain. For migraine prevention, the first dose is 240 mg, then 120 mg each month. For cluster headaches, the dose is 300 mg at the start of a cluster period and then monthly until the period ends. The approval was based on studies showing that Emgality reduced the number of migraine days per month compared to a placebo. It is not for people who have had a recent heart attack or stroke. Also, it is not approved for chronic cluster headaches. This approval gives patients a new treatment option that is easy to use. However, it is important to talk to your doctor about whether Emgality is right for you. Your doctor can help you understand the benefits and risks based on your health history.
FDA approved Emgality (galcanezumab) for Preventive Treatment of Migraine and Episodic Cluster HeadacheFDA approved new monthly shot Emgality to prevent migraines and treat cluster headaches.
AI-generated summary of the cited source, checked by automated accuracy review. How we work
The FDA has approved Emgality (galcanezumab), a calcitonin gene-related peptide (CGRP) antagonist, for the preventive treatment of migraine and the treatment of episodic cluster headache in adults. The approval provides a new monthly injectable option for patients with these debilitating headache disorders. For migraine, the recommended dosing is a 240 mg loading dose followed by 120 mg monthly. For episodic cluster headache, the dose is 300 mg at the onset of the cluster period and then monthly until the period ends. The efficacy for migraine was established in two 6-month placebo-controlled trials enrolling patients with 4 to 14 migraine days per month. Emgality 120 mg demonstrated statistically significant reductions in monthly migraine days compared with placebo. Clinicians should note that the label excludes patients with recent cardiovascular events, and the drug is not indicated for chronic cluster headache.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Emgality (galcanezumab) is a calcitonin-gene related peptide (CGRP) antagonist. It binds to CGRP and blocks its activity.
Emgality is indicated in adults for: preventive treatment of migraine; treatment of episodic cluster headache.
For subcutaneous use only. Migraine: 240 mg loading dose (two consecutive 120 mg injections) followed by monthly 120 mg. Episodic cluster headache: 300 mg (three consecutive 100 mg injections) at onset of cluster period, then monthly until end of cluster period. Allow to sit at room temperature for 30 minutes before administration. Do not shake. Administer in abdomen, thigh, back of upper arm, or buttocks.
Migraine: Efficacy evaluated in two 6-month, randomized, double-blind, placebo-controlled studies (Studies 1 and 2) in adults with episodic migraine (4-14 migraine days/month). Patients received Emgality 120 mg (with 240 mg loading dose), 240 mg, or placebo. Primary endpoint: mean change from baseline in monthly migraine headache days over 6 months. In Study 1 (N=858), mean baseline ~9 migraine days/month. Emgality 120 mg showed statistically significant improvement vs placebo. In Study 2 (N=915), similar results. Key secondary endpoints included 50%, 75%, 100% responder rates, acute medication use, and MSQ v2.1 Role Function-Restrictive domain score. Episodic cluster headache: trial data not available in label.
Not reported in label.
Emgality is a CGRP antagonist approved for migraine prevention and episodic cluster headache treatment. It is administered monthly subcutaneously. The label notes exclusion of patients with recent cardiovascular events in clinical trials. It is not indicated for chronic cluster headache.
View Original Abstract ↓
Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke
Tenecteplase improves stroke recovery but increases bleeding risk in late treatment window
Related in Neurology
From Other Specialties
