FDA Grants Approval to Amneal’s Brekiya for Migraine and Cluster Headaches

The U.S. Food and Drug Administration (FDA) has approved Brekiya, an injectable treatment developed by Amneal Pharmaceuticals, for the acute treatment of migraines and cluster headaches in adults. This approval marks a significant milestone, as Brekiya becomes the first dihydroergotamine mesylate (DHE) auto-injector to gain FDA approval.

Addressing a Widespread Neurological Burden

Headache disorders, particularly migraines, are among the most prevalent neurological conditions globally. According to the World Health Organization, migraines affect approximately 39 million people in the U.S. alone. These debilitating attacks often last between four and 72 hours and are frequently accompanied by intense pain, nausea, vomiting, and sensitivity to light and sound.

Cluster headaches, though less common, still impact about one million Americans. These headaches are known for their brief but excruciating pain, typically centered around one eye, and tend to occur in cyclical patterns.

A Hospital-Grade Treatment, Now in Patients’ Hands

DHE has long been used in hospital settings due to its rapid onset of action and effectiveness in both relieving migraines and preventing their recurrence. Traditionally administered intravenously in emergency rooms, DHE treatments have not been widely accessible for self-use—until now.

Brekiya changes this landscape, providing patients with a ready-to-use, single-dose auto-injector. The device is designed for subcutaneous injection into the thigh, requires no refrigeration or assembly, and offers a convenient way to manage severe headaches at home.

Empowering Patients with Faster Relief

Joe Renda, Amneal’s Senior Vice President and Chief Commercial Officer – Specialty, emphasized the importance of this innovation:

“Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose auto-injector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room.”

Availability Timeline

Brekiya is expected to become commercially available in the second half of 2025 for eligible patients, offering a much-needed self-care option for those battling disabling headache disorders.