- An experimental pain medication from Eli Lilly significantly outperformed placebo at reducing the number of weekly cluster headache attacks for patients who experience them intermittently, according to data released Tuesday.
- In a Phase 3 study of episodic cluster headache patients, those who took Lilly's galcanezumab had 8.7 fewer weekly attacks after three weeks of treatment compared to 5.2 fewer attacks for those on placebo. Lilly also tested the drug in patients with chronic cluster headaches, but that separate investigation didn't meet its primary endpoint.
- The Food and Drug Administration is already reviewing a Biologics License Application for galcanezumab in the adult migraine prevention setting. Lilly expects an approval decision during the third quarter.
With the diabetes space facing pricing pressures and Alzheimer's disease remaining a risky bet, Lilly has turned to pain management drugs to buttress its late-stage pipeline.
There, the company expects substantial returns on galcanezumab, one of just a handful of calcitonin gene-related peptide (CGRP) inhibitors in advanced clinical trials. While Lilly awaits an FDA decision for the migraine prevention indication, it's also been laying the groundwork for label expansions into other areas like cluster headache.
"What cluster does for galcanezumab from a business standpoint is it demonstrates the efficacy of the product. If you can treat a cluster headache, which is the worst kind of migraine out there, then there is no question that you are effective in the broader class of migraine," Christi Shaw, president of Lilly Bio-Medicines, told BioPharmaDive in a March 9 interview.
That efficacy profile will be important, as a series of new migraine medications are barreling toward the market.
In the CGRP arena alone there's Novarits and Amgen's Aimovig (erenumab), which has a target action date of May 17; Teva Pharmaceutical's fremanezumab; and Alder Biopharmaceuticals' eptinezumab. Like galcanezumab, each is for migraine prophylaxis. There's also Allergan's oral CGRP inhibitor, ubrogepant, under investigation for acute treatment of migraine.
The considerable competition will make labels a vital tool for securing market share.
"With the payers, multiple indications — not just multiple assets, but multiple indications are important," Shaw said in the interview.
Lilly's latest data could help on the indications front. Despite the miss in chronic cluster headache, galcanezumab hit both the primary and gated secondary endpoint of the episodic cluster headache trial. A significantly higher percentage of patients taking the drug experienced at least a 50% reduction in weekly cluster headache attacks compared to placebo at Week 3.
The safety profile also appeared fairly clean, with 4% of patients in the experimental arm discontinuing treatment due to adverse events versus 2% of patients in the placebo arm.
Ned Pagliarulo contributed reporting to this article.