FDA approves Amneal’s self-administered migraine drug Brekiya

Brekiya is now the first DHE auto-injector to be approved by the regulator

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ Brekiya (dihydroergotamine mesylate) injection to treat acute migraine and cluster headaches in adults.

The therapy, which is expected to be available for eligible patients in the second half of 2025, is now the first dihydroergotamine (DHE) auto-injector to be approved by the regulator.

Headache disorders are among the most common disorders of the nervous system, according to the World Health Organization. Affecting approximately 39 million people in the US, migraines usually last between four and 72 hours and are associated with symptoms such as a throbbing pain, nausea, vomiting, and increased sensitivity to light and sound.

Cluster headaches are less common, occurring in around one million people in the US. The condition is characterised by frequently recurring, brief but extremely severe headaches, usually focused in or around one eye.

Typically given intravenously in emergency rooms and urgent care facilities, DHE is a fast-acting treatment that can help relieve migraine attacks and may protect patients from headache recurrence.

Amneal’s Brekiya injection will now give patients the option to self-administer the same drug used in hospitals in a ready-to-use device.

Patients can deliver one dose subcutaneously into the middle of their thigh, and the autoinjector does not require refrigeration or assembly.

Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty, said: “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.”