Eli Lilly's galcanezumab hits main goal in episodic cluster headache study, fails in chronic trial

Eli Lilly said Tuesday that a Phase III study of galcanezumab in patients with episodic cluster headache met its primary endpoint, although another late-stage trial of the experimental CGRP inhibitor in patients with chronic cluster headache failed to hit its main goal. Christi Shaw, president of Lilly Bio-Medicines, commented "the positive results in episodic cluster headache are truly a landmark moment."

In the first study, 106 patients with episodic cluster headache were randomised to receive once-monthly galcanezumab or placebo. Results showed that patients treated with Eli Lilly's drug experienced significant differences in the reduction of weekly cluster headache attacks compared to those given placebo across weeks one to three.  

Specifically, patients who received galcanezumab experienced 8.7 fewer migraines a week over the three-week period, compared to a reduction of 5.2 headaches per week in the placebo group. Data also showed that a significantly greater proportion of patients in the galcanezumab arm achieved the gated secondary endpoint of an at least 50-percent decline in the weekly frequency of cluster headache attacks. Eli Lilly noted that the safety and tolerability of the drug were consistent with prior findings, with 8 percent of galcanezumab-treated patients discontinuing, versus 21 percent for the placebo group.  

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Meanwhile, the second trial randomised 237 patients with chronic cluster headachgve to receive once-monthly galcanezumab or placebo. The study failed to meet its main goal of the overall mean change from baseline in weekly cluster headache attack frequency during the three-month treatment phase. The drugmaker said that based on results from the episodic cluster headache trial, it will work "with regulatory agencies around the world to determine the best path forward."

Eli Lilly disclosed last year that galcanezumab met the primary endpoint in three Phase III studies of patients with chronic and episodic migraine. The FDA accepted a submission seeking approval of the drug in December 2017, with a final decision expected by the third quarter. Eli Lilly regained rights to galcanezumab from Arteaus Therapeutics in January 2014, later identifying the treatment as one of as many as 20 products that could be launched by 2023.

Meanwhile, the FDA is expected to issue a final decision concerning the approval of Amgen and Novartis' CGRP antibody Aimovig (erenumab) by May 17 after accepting the drugmakers' filing in July last year (for related analysis, see ViewPoints: Amgen looking to avoid Repatha 2.0 with Aimovig launch, and Physician Views Results: Pricing and access the biggest concern for Amgen, Novartis' Aimovig).

For related analysis, see ViewPoints: Galcanezumab’s cluster success – small market or big difference?

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