FDA Approves First-of-its-Kind Acute Migraine Treatment

Migraine

Months after winning approval for Emgality as a treatment for episodic cluster headache, Eli Lilly scored another victory in the migraine area. The U.S. Food and Drug Administration (FDA) approved Reyvow (lasmiditan) for the acute treatment of migraines.

The approval of Reyvow marks the first for this type of medicine class called ditan. Lasmiditan is a centrally-penetrant, selective serotonin (5-HT)1F receptor agonist, Eli Lilly said. Reyvow, which has a unique mechanism of action, was approved for migraine with and without aura. The approval of Reyvow follows a wave of calcitonin gene-related peptide (CGRP) inhibitors approved for migraine, including Emgality, which was also approved for the prevention of migraine in 2018.

Migraine headache pain is typically described as an intense pain in one area of the head. In addition to the pain, migraine sufferers can experience nausea, sensitivity to light and sound, as well as an aura. According to the FDA, about one-third of people who suffer from migraine experience auras ahead of the onset of pain, which can appear as flashing lights, zig-zag lines, or even as a temporary loss of vision.

Gudarz Davar, head of neurology development at Lilly Bio-Medicines, said there’s a “substantial unmet need” for new acute migraine treatments like Reyvow. The drug, Davar said, can help millions of migraine sufferers with unresolved pain and symptoms.

“New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine."

The approval of Reyvow was based on results from two Phase III trials, SPARTAN and SAMURAI, which both met primary endpoints of alleviating pain in migraine patients, as well as the most bothersome symptoms, which includes the nausea and sensitivity to light or sound. The alleviation of pain and the symptoms typically occurred within two hours of taking the medication, Eli Lilly said. The Reyvow Phase III development program, also included the open-label GLADIATOR study, involved more than 4,000 patients and the treatment of more than 20,000 migraine attacks. Interim results from GLADIATOR released earlier this year showed safety and efficacy remained consistent with results from SPARTAN and SAMURAI.

There were some mild adverse effects from the drug, such as dizziness or fatigue. However, Eli Lilly noted that there is a potential for abuse of Reyvow, as there is in other medications for the central nervous system. Reyvow is currently being evaluated by the U.S. Drug Enforcement Agency as a potential controlled substance. That classification review is expected to be completed within the next three months. Once that review is complete, the medication will be available in retail pharmacies, Eli Lilly said.

Nick Kozauer, acting deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said Reyvow is a new option for migraine sufferers. Migraine, Kozauer said at the time of Reyvow’s approval, affects one in seven Americans.

“We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” Kozauer said in a statement.

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