Lilly's scored its cluster headache nod for Emgality. Will it shake up the CGRP race?

Emgality scored its second FDA approval Tuesday to treat cluster headaches. (Eli Lilly)

Eli Lilly's Emgality didn't just hit the next-generation migraine market in third place behind Amgen and Novartis' Aimovig and Teva's Ajovy. It's been trailing its CGRP rivals in early sales results, too. But now, Emgality is alone in boasting a cluster headache approval. 

Tuesday, the FDA approved Emgality to treat patients with cluster headache during a cluster period. The nod followed a breakthrough designation—which the FDA grants to treatments for patients who lack other options—and a priority review granted earlier this year. It's now the only FDA-approved drug for the condition.

Lilly is expecting quick uptake, because cluster headache patients are "very motivated" to find new treatments and have felt "marginalized" for years, Eric Pearlman, senior medical director in neuroscience at Lilly, said in an interview. Patients describe the pain as a knife or hot poker to the eye, Pearlman noted, and their eyes can grow teary, swell and redden. They're often misdiagnosed—leading to unnecessary eye surgeries, sinus surgeries or tooth extractions.

“We’re not talking about a second indication for Emgality,” Pearlman said. “We’re talking about an innovative therapy for 250,000 patients [in the United States].”

As Lilly's vice president of neuroscience Libby Driscoll said, cluster headaches are actually “very different” from migraines. They're unpredictable, sudden attacks that happen for weeks or months at a time. And whereas migraine patients often retreat to a dark room, cluster headache patients are agitated and restless, Pearlman said. Some injure themselves as a consequence of the pain.

RELATED: Lilly's third-to-market Emgality nets FDA 'breakthrough' in cluster headache 

Emgality's cluster headache dosing will differ, too. For migraine prevention, it's dosed on an ongoing basis, but for cluster headaches, patients will only take the drug during attacks. They’ll get 300 mg at the onset of a cluster period, and then follow-up subcutaneous injections each month until the end of the period. Cluster periods can last several months.

Emgality’s second indication—specifically, to reduce the number of attacks during a cluster period—comes after the drug’s original approval last September. In migraine prevention, the drug is racing against Amgen and Novartis’ first-to-market Aimovig and Teva’s Ajovy.

RELATED: Teva abandons Ajovy's cluster headache ambitions, clearing a path for Lilly to forge a new market 

And though Teva might have challenged Emgality in cluster headache at some point, that's not going to happen now. Teva called off its plans to seek cluster headache approval after an early phase 3 trial analysis showed the drug was unlikely to hit its primary endpoint.

In the first quarter of 2019, Aimovig generated $59 million in sales, while Ajovy pulled in $20 million and Emgality reaped $14 million. The drugmakers have offered free drugs to get patients on treatment while payers iron out coverage. CGRP drugs carry list prices of $6,900 per year before discounts, and payers have generally endorsed the new set of medicines.

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