New molecular entity
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Feb 19 · Alder has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) .
May 18 · Analysts predict launch in US in 2020, and in territories outside the US in 2021 .
Jun 17 · Alder plans to file a biologics license application (BLA) submission to the FDA in the second half of 2018 .
Human monoclonal antibody that works by inhibiting the calcitonin gene-related peptide receptor believed to transmit signals that can cause incapacitating pain.
Numbers may be misleading, as many who experience migraine do not consult their GP, but migraine affects about 6% of men and 18% of women. In children it is more common in boys than in girls. The first attack is often in childhood and over 80% have had their first attack by the age of 30 .
Trial or other data
Jul 19 · Post-hoc analyses of PROMISE-1 and PROMISE-2 demonstrate efficacy of eptinezumab for migraine prevention. Results showed 63.3% of episodic migraine patients & 34.6 % of chronic migraine patients treated with 100 mg eptinezumab achieved at least one migraine-free month, over a 1-year and 6 month study, respectively vs. 12.6% and 22.4% of placebo patients .
Jan 18 · Eptinezumab met the primary endpoint in pivotal PIII PROMISE 2 trial. Top line results show that following a single quarterly eptinezumab administration, the primary endpoint was met: reduction of 8.2 monthly migraine days from baseline vs. 5.6 days for placebo, p<0.0001. Eptinezumab met all key secondary endpoints including prevention beginning Day One (p<0.0001) and 50% (p<0.0001) and 75% (p<0.0001) responder rates months 1-3. Furthermore, 15% of eptinezumab patients had no migraines (i.e., 100 percent response) for a full 3 months (p<0.0001 unadjusted). Safety and tolerability were similar to previously reported eptinezumab studies.
Jul 17 · Recruitment to PIII NCT02974153 is ongoing. PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2) is evaluating the safety and efficacy of two dose levels of eptinezumab versus placebo, administered by infusion once every 12 weeks in patients living with chronic migraine. .
Jun 17 · Results from PIII PROMISE 1 trial show a superior reduction in monthly migraine days for eptinezumab vs placebo (4.3 vs 3.2 days, p=0.0001). The % of patients with ≥75% reduction in monthly migraine days was 31.5% for eptinezumab 300 mg vs 20.3% for placebo (p=0.0066) .