Lilly plans 2018 filing for acute migraine drug after second phase 3 win – via

Eli Lilly‘s bid to bring a new class of migraine therapy to market has just been lifted by a second positive trial that sets up first-marketing applications next year.

The top-line results of the SPARTAN trial show that oral serotonin 5-HT1F agonist lasmiditan provided relief from the headache pain and other symptoms associated with acute migraine attack, such as nausea and aversion to light or loud sounds, in as little as two hours, matching the results of its earlier SAMURAI study.
With a dose of 50mg, 28.6% of patients were headache-free at two hours, rising to 31.4% at the 100mg dose and 38.8% of those on 200mg.  The placebo response rate was 21.3%.  Upwards of 40% of patients in all three dose groups were also free of their most bothersome symptom other than headache, compared to a third (33.5%) of the placebo group.
While expected, the outcome of the trial is a relief to Lilly which forked out nearly $1 billion in January to buy out lasmiditan developer CoLucid Pharmaceuticals, claiming back the drug which it discovered and licensed out to CoLucid in 2005.  If approved, lasmiditan would be a good pairing for Lilly’s other big migraine hope galcanezumab, a CGRP inhibitor which, rather than treating acute attacks, works as a maintenance therapy to try to stop them occurring in the first place.  Lilly is competing with rivals Teva and Alder Biopharma to bring the first CGRP inhibitor to market.

Lasmiditan represents the first significant innovation in the acute treatment of migraine in more than 20 years.  The first-in-class drug could provide a much-needed new treatment option for the 36 million Americans living with migraine.

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