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Lilly’s migraine drug succeeds in Phase 3 trials

Published on 15/05/17 at 09:34am

Eli Lilly announced the successful results of three Phase 3 trials examining the benefits of its drug, galcanezumab, in patients with episodic and chronic migraines. The results poise Lilly to take the drug to the FDA, establishing it as a competitor to Amgen and Novartis’ erenumab as they too plan to take their migraine drug through to the FDA for a decision.

The trials in Lilly’s drug found that it was able to limit the number of days with migraines by an average of 4 and a half days. The three trials pitted two different doses of the drug against a placebo, finding that the drug boosted days without migraines by two days over the action of the placebo.

The higher dosage of the drug, at 240mg, displayed poorer outcomes against the 120mg dosage – with a range of 4.3-4.8 days of improvement against 4.2-4.6 in the higher dose. Placebo treatment averaged an improvement of 2.6 days without migraines.

Patients in the EVOLVE 1 and 2 arm of the trials suffered from episodic migraines and had to experience 4 to 14 migraines per month. While the REGAIN study contained patients with chronic migraines who suffered a minimum of 15 days of migraines per month.

"The robust results from these three studies bring us one step closer to helping people experience more migraine-free days, an important treatment goal for those living with this serious disease," said Christi Shaw, President of Lilly Bio-Medicines. "The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements. For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year."

The results place Lilly well to take the drug to the FDA and achieve approval. The question for Lilly will be how it differentiates this treatment from Amgen and Novartis’ drug, which also targets the activity of the calcitonin gene-related peptide – thought to play a role in pain and migraines.

Beyond Amgen and Novartis, Teva and Alder Biopharmaceuticals have all scored similar successes in treatment but without any stand-out results, indicating that the area could become a highly competitive field.

Ben Hargreaves

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