Lilly files new class migraine drug with FDA

The US pharma added that the regulator has granted its Emgality (galcanezumab) Breakthrough Designation for prevention of episodic cluster headache, building on a previous approval in another form of migraine.

An oral drug, lasmiditan is a selective serotonin 5-HT1F agonist that Lilly says is distinct from other approved migraine therapies and does not cause constriction of blood vessels.

Lilly noted that it is the first and only molecule in the "ditan" class under evaluation for acute treatment of migraine in adults.

The company said it could represent the first significant innovation for the acute treatment of migraine in more than two decades.

The filing for lasmiditan includes data from two phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of lasmiditan for the acute treatment of migraine.

In both studies, at two hours following the first dose of lasmiditan, the percentage of patients who were migraine pain-free was significantly greater compared to placebo. These results were significant across all studied doses.

Lasmiditan also met the key secondary endpoint, with a significantly greater percentage of patients free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose.

In these studies, patients chose their MBS from sensitivity to light, sensitivity to sound or nausea. The most commonly reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea, muscle weakness and numbness.

Emgality, from the calcitonin gene-related peptide (CGRP) antagonist class, was approved by the FDA for preventive treatment of migraine in adults in September.

Amid competition from rival CGRP drugs from Novartis/Amgen and Teva, Lilly hopes to file Emgality to treat highly disabling cluster headaches by the end of the year.

The FDA grants Breakthrough Therapy status to drugs that could represent a substantial improvement over available therapies for serious or life-threatening diseases.

There are no approved preventive treatments for episodic cluster headache in the US.

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