=Eli Lilly (LLY) : endpoint data for lasmiditan

Eli Lilly present key primary and secondary endpoint data for lasmiditan; plans to submit a NDA to the FDA in the second half of 2018

• Co presents key primary and secondary endpoint data for lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, which demonstrated statistically significant improvements compared to placebo in the Phase 3 SPARTAN study.
• These findings are consistent with SAMURAI, the first pivotal Phase 3 study evaluating the safety and efficacy of lasmiditan for the acute treatment of migraine. The most commonly-reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea and lethargy.
• Lilly plans to submit a New Drug Application for lasmiditan to the FDA in the second half of 2018.
• Lilly will submit the results to a peer-reviewed journal within the next year. An open-label Phase 3 study-GLADIATOR-is also underway evaluating the long-term safety of lasmiditan for the acute treatment of migraine.

Eli Lilly (LLY) also announced that data across its immunology portfolio will be presented at the annual European Academy of Dermatology and Venereology Congress (EADV), including Phase 2 safety and efficacy data evaluating Olumiant (baricitinib) for the treatment of moderate-to-severe atopic dermatitis (Lilly and Incyte Corporation are partners on the development of Olumiant). EADV will take place Sept. 13-17, 2017, in Geneva, Switzerland.