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Eli Lilly's Cluster Headache Candidate Succeeds in Phase III

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Eli Lilly & Company’s LLY pipeline candidate, galcanezumab met its primary as well as secondary endpoint in a late-stage study evaluating it for the prevention of episodic cluster headache.

The study (n=106) showed that treatment with galcanezumab(300 mg once-monthly) led to statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month treatment period — the primary endpoint. Meanwhile, at week 3, a statistically significantly greater percentage of patients in the galcanezumab arm achieved at least a 50% reduction in weekly cluster headache attacks (secondary endpoint) compared to placebo. Safety and tolerability were consistent with previous studies evaluating galcanezumab for migraine prevention. Lilly said it will work with regulatory authorities to determine the best path forward for the candidate.

However, a separate phase III study (n=237) evaluating galcanezumab in patients with chronic cluster headache did not meet the primary endpoint. According to Lilly’s press release, chronic cluster headache represents 10% to 15% of cluster headache cases. Episodic cluster headache accounts for 85%-90% of the cluster headache market.

Galcanezumab is already under review in the United States for migraine prevention with a decision expected in the third quarter of the year.

Galcanezumab uses calcitonin gene-related peptide (CGRP) antibody for the prevention of migraine. Amgen AMGN and partner Novartis’ NVS Aimvog/erenumab and Teva Pharmaceutical Industries Limited’s TEVA fremanezumab have been developed for chronic/episodic migraine prevention using anti-CGRP mechanism and are also under review in the United States. A FDA decision on fremanezumab was expected in June. However, earlier this month, Teva informed that it does not expect to get FDA approval for fremanezumab on its PDUFA date in June. This is because Teva’s manufacturing partner for fremanezumab, Celltrion, which makes the API, received a warning letter from the FDA this year that delayed the approval of the drug. However, Teva expects fremanezumab to be approved and launched before the end of this year.

Meanwhile, the FDA action date for Amgen’s CGRP antibody, Aimovig, for the prevention of migraine, is May 17. Amgen looks confident to gain FDA approval, which will make it the first medicine in the CGRP class to get approval.

Year to date, Lilly’s shares have declined 2.6% compared with the industry’s decline of 2.9%.


Lilly currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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