Lilly Bio-Medicines President Christi Shaw characterizes positive results from late-stage research for a potential headache treatment as "truly a landmark moment." Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says galcanezumab met its primary goal of reducing weekly cluster headache attacks. The treatment, however, missed its primary endpoint on a separate study focusing on chronic cluster headaches.
Shaw says "cluster headache can be difficult to evaluate in clinical studies, which has contributed to few available treatment options for cluster headache, often considered the most severe pain one can experience. The positive results in episodic cluster headache are truly a landmark moment – both for people living with cluster headache and for our researchers at Lilly, many of whom have spent more than two decades researching and developing innovative, non-opioid treatment options for diseases like migraine and cluster headache."
Lilly says the Phase 3 study results are driving it to work with regulatory agencies throughout the world to figure out how to proceed. The studies involved a total of 343 patients, which the pharmaceutical maker says is the largest-ever controlled preventive cluster headache trials.
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