Migraine (Adult)

September 18, 2017

Eli Lilly reported results of a phase III study of galcanezumab for migraine. In the 12-month, open-label study, 270 patients were randomized to treatment with galcanezumab 120mg or galcanezumab 240mg. Galcanezumab was associated with a statistically significant reduction in the number of monthly migraine headache days with both doses (5.6 days for 120mg and 6.5 days for 240mg, p<0.001 for both dosing groups). Notably, there was no clinically meaningful difference in the rate of adverse events between galcanezumab 120mg and 240mg dosing groups. The most commonly reported adverse events (≥10%) in both dosing groups included injection site pain, nasopharyngitis and upper respiratory tract infection. Serious adverse events were reported by three patients in the 120mg dosing group and seven patients in the 240mg group. Lilly plans to submit a Biologics License Application (BLA) to the FDA for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

July 3, 2017

Alder BioPharmaceuticals issued results of a phase III study of eptinezumab for frequent episodic migraine. PROMISE 1 was a double-blind, randomized, placebo-controlled study evaluating eptinezumab (300mg, 100mg or 30mg) administered by intravenous infusion once every 12 weeks through week 24. PROMISE 1 met the primary endpoint: highly statistically significant reductions in monthly migraine days. Significant Day 1 clinical benefit was a ≥50% reduction in the proportion of patients experiencing a migraine on Day 1 post-dose. There were significant 75% responses at all key time points: ~1/3 of patients achieved a ≥75% reduction in migraine days through four and 12 weeks. An average of one in five patients had 100% response: no migraines in any given month, months one through six. Enrollment is on track for PROMISE 2, a second pivotal phase III study that focuses on chronic migraine, and the company is on track to submit a BLA with the FDA in 2018.

June 19, 2017

Eli Lilly released results from three phase III studies of galcanezumab for the prevention of episodic and chronic migraine. In the EVOLVE-1 and EVOLVE-2 studies, over the six-month treatment period, patients with episodic migraine treated with galcanezumab 120mg and 240mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo, with statistically significant improvements observed at each month starting at one month of treatment. A statistically significantly greater percentage of patients treated with both doses of galcanezumab achieved at least a 50%, 75% and 100% reduction in the number of migraine headache days compared to placebo over the six-month treatment period, in both studies after multiplicity adjustment. In the REGAIN study, over the three-month treatment period, patients with chronic migraine treated with galcanezumab 120mg and 240mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo. Statistically significant improvements for both doses of galcanezumab were observed at each month starting at one month of treatment. A statistically significantly greater percentage of patients also achieved at least a 50% reduction in the number of migraine headache days compared to placebo over the three-month treatment period (27.6% for 120mg and 27.5% for 240mg compared to 15.4% for placebo, p<0.001 for both dosing groups) after multiplicity adjustment. Based on these results, Lilly will submit a Biologics License Application to the FDA for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

June 5, 2017

Teva Pharmaceutical Industries announced positive results from a phase III HALO study of fremanezumab, an investigational treatment for the prevention of migraine. In the chronic migraine (CM) study, patients treated with fremanezumab experienced statistically significant reduction in the number of monthly headache days of at least moderate severity vs. placebo (-2.5 days) during the 12 week period after first dose, for both monthly (-4.6 days p<0.0001) and quarterly (-4.3 days p<0.0001) dosing regimens. Similar to the Phase II trials, both patients that were on monotherapy and stable doses of prophylactic medications were included in the trial. In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability. The results were positive, and of 13 hierarchical comparisons, p was <0.0001 in 12 of them, being 0.0004 in the remaining. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups. Based on these results, Teva plans to submit a Biologics License Application to the FDA for fremanezumab later this year.

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