Eli Lilly to present new data on Emgality, Lasmiditan at AAN annual meeting

Emgality is also currently under Priority Review by the FDA as an investigational drug for the preventive treatment of episodic cluster headache in adults.

New Delhi: Eli Lilly and Company recently announced it will present 19 scientific abstracts for Emgality (galcanezumab-gnlm) and lasmiditan at the 71st Annual Meeting of the American Academy of Neurology (AAN) taking place in Philadelphia from May 4-10, 2019.

Emgality (120 mg) is indicated for the preventive treatment of migraine, Emgality (300 mg) is an investigational drug for the preventive treatment of episodic cluster headache, and lasmiditan is an investigational drug for the acute treatment of migraine, all in adults.

The data to be presented further establish Lilly's breadth of research and clinical programs aimed at developing innovative approaches to the treatment of debilitating and difficult-to-treat headache disorders.

Commenting on the same, Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines said, "Migraine and episodic cluster headache are extremely debilitating disorders, and we are committed to finding good treatment options for those living with these neurologic diseases."

"The data presented at AAN reflect Lilly's deep commitment and expertise in searching for and finding solutions for some of today's toughest challenges in migraine and disabling headache disorders," said Dr Davar added.

In a plenary session on May 7, 2019, Lilly will highlight Phase 3, eight-week findings for Emgality as an investigational preventive treatment for episodic cluster headache in adults. On May 6, 2019, Lilly will also present analyses from two Phase 3 studies (EVOLVE-1 & EVOLVE-2) evaluating Emgality in a subgroup of adults living with episodic migraine, by low- versus high-frequency of migraine headache days.

Lilly will also share new data for lasmiditan, including details on the onset of efficacy, in a platform presentation on May 6, 2019, and in a poster presentation based on clinical data from the Phase 3 GLADIATOR long-term extension study. Lasmiditan is an oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity. It is the first and only molecule in the "-ditan" class under evaluation by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. If approved, it could represent the first significant innovation for the acute pharmacological treatment of migraine in more than two decades.

Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP) which was approved by the FDA in September 2018 for the preventive treatment of migraine in adults and in Europe for the prophylactic treatment of migraine in adults who have at least four migraine days per month. Emgality is also currently under Priority Review by the FDA as an investigational drug for the preventive treatment of episodic cluster headache in adults.

Emgality represents the first of three investigational treatments in development as part of Lilly's overall pain portfolio. The portfolio also includes lasmiditan, an investigational drug for the acute treatment of migraine in adults and tanezumab, developed in partnership with Pfizer, which is being investigated for the treatment of osteoarthritis pain, chronic low back pain and cancer pain in adults.

Lasmiditan is an investigational, oral, first-in-class molecule under evaluation for the acute treatment of migraine in adults. Lasmiditan selectively targets 5-HT1F receptors expressed in the trigeminal pathway and has been designed for the acute treatment of migraine without the vasoconstrictor activity associated with some migraine therapies.

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