Posted by Michael Wonder on 14 Nov 2018
Lilly submits new drug application to the FDA for lasmiditan for acute treatment of migraine, receives breakthrough therapy designation for Emgality (galcanezumab-gnlm) for prevention of episodic cluster headache
14 November 2018 - Lilly also plans to submit a supplemental biologics license application to the FDA for Emgality for the preventive treatment of episodic cluster headache by the end of the year, reflecting its commitment to disabling headache disorders.
Eli Lilly and Company has announced the submission of a new drug application to the U.S. FDA for lasmiditan for the acute treatment of migraine with or without aura in adults.
Lasmiditan is an investigational, 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 for the acute treatment of migraine in adults. If approved, it could represent the first significant innovation for the acute treatment of migraine in more than two decades.
