Eli Lilly and Daiichi Sankyo Announce Commercialization Agreement for 5-HT1F Agonist Reyvow (Lasmiditan) in Japan

Eli Lilly and Daiichi Sankyo recently jointly announced that they have reached an agreement on a commercialization collaboration in Japan for the 5-HT1F receptor agonist Reyvow (lasmiditan). Eli Lilly has submitted a New Drug Application (NDA) in Japan for Reyvow for the acute treatment of migraine.

Previously, the two parties had signed an agreement regarding the sales in Japan of Eli Lilly's monoclonal antibody migraine drug Emgality (galcanezumab), a humanized anti-calcitonin gene-related peptide (CGRP) monoclonal antibody produced via recombinant DNA technology for the prophylactic treatment of migraines.

Similar to Emgality, under the terms of the newly reached agreement, Eli Lilly will hold the commercialization rights for Reyvow in Japan, and upon approval, Daiichi-Sankyo will be responsible for its distribution and sales. Both companies will provide information regarding the drug to healthcare professionals.

Based on its position and network in the field of central nervous system diseases and pain management, Daiichi Sankyo maintains a solid business foundation in Japan. Through the commercialization collaboration with Daiichi Sankyo, Eli Lilly Japan will, upon marketing approval, strengthen its system for providing appropriate information to healthcare professionals regarding Emgality and Reyvow.

Daiichi-Sankyo will improve the quality of life for more migraine patients by providing comprehensive care support through Emgality for migraine prevention and Reyvow for acute migraine treatment. Eli Lilly and Daiichi-Sankyo will advance migraine healthcare in Japan through a commercialization partnership for the two drugs.

Migraine is a common chronic neurovascular disorder characterized by recurrent attacks of severe headache, typically unilateral. Currently, no medication can cure migraine. The World Health Organization (WHO) has ranked migraine as one of the top 10 most disabling diseases worldwide.

Reyvow is an oral prescription medication approved by the U.S. FDA in October 2019 for the acute treatment of migraine with or without aura in adults. Reyvow represents the first new class of acute migraine treatments approved by the FDA in over 20 years. As the first FDA-approved 5-HT1F receptor agonist, it acts on both the central and peripheral nervous systems, with a mechanism of action distinct from other currently marketed acute migraine therapies. Please note that Reyvow is not indicated for the preventive treatment of migraine. The medication is available in dosage strengths of 50 mg, 100 mg, and 200 mg, allowing for flexible dose selection as needed.

In clinical studies, a single dose of Reyvow rapidly and completely eliminated migraine pain and the most bothersome symptom (nausea, photophobia, or phonophobia) in just 2 hours. The latest guidance issued by the US FDA and the American Headache Society has raised clinical standards, recommending that efficacy in clinical trials for migraine medications must demonstrate pain freedom and freedom from the most bothersome symptom, rather than merely pain relief. Reyvow is the first FDA-approved acute migraine treatment to meet this new standard.

The active pharmaceutical ingredient of Reyvow is lasmiditan, an oral, CNS-penetrant, selective serotonin 1F (5-HT1F) receptor agonist that is structurally and mechanistically distinct from currently approved migraine medications and lacks vasoconstrictive activity. Notably, lasmiditan is the first and only approved drug molecule of the "-ditan" class for the acute treatment of migraine in adults.

Note: The original text has been abridged.

Original Source: Eli Lilly Japan and Daiichi Sankyo Enter a Collaborative Agreement to Commercialize Lasmiditan Succinate in Japan for the Acute Treatment of Migraines

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