FDA approves migraine drug as the first cluster headache treatment

As many as 1 million Americans who suffer with cluster headaches may finally get some relief with the approval of the first drug specifically designed to treat the rare but devastating condition that affects mostly younger men.

Patients often have to take medications that have significant side effects such as swelling of the legs. But on Tuesday, the Food and Drug Administration approved a new treatment — a once monthly injection, Emgality, made by Eli Lilly.

In a recent clinical trial, the drug was shown to significantly reduce the number of cluster headache attacks — from an average of eight headaches per week to five per week — with few side effects.

“Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,” Dr. Eric Bastings, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

Emgality belongs to a new class of drugs called CGRP inhibitors that are used to prevent migraines or reduce their frequency. It’s one of three drugs in this drug class for migraines that have been released in the past year.

“The study wasn’t very long, it was only for three weeks, but these drugs are interesting and have a lot of potential,” Dr. Alan Shepard, neurologist and headache specialist at Northwestern Memorial Hospital, said. “Its something we will be trying more in the future.”