Novartis, Amgen score Phase 3 win for migraine drug
- An experimental drug in joint development by Amgen and Novartis succeeded in reducing the number of monthly migraine days among patients suffering from episodic migraine, hitting its primary endpoint in a Phase 3 trial, the companies said Wednesday.
- The positive results for the drug, known as AMG 334, come on the heels of a Phase 2 win earlier this year in chronic migraine.
- AMG 334 is designed to block the calcitonin gene-related peptide receptor (CGRP) in order to alleviate the excruciating pain felt by sufferers of episodic and chronic migraines. Teva, Eli Lilly and Alder BioPharmaceuticals are also developing CGRP drugs but AMG 334 appears to be the most advanced.
Amgen and Novartis hope to beat out the CGRP competition and the latest positive data on AMG 334 should help the drugmakers stay on track to do so.
In the 577-patient study, once-monthly treatment with AMG 334 lead to a statistically significant 2.9-day reduction in monthly migraine days compared to baseline, beating out a 1.8-day reduction seen among those on placebo.
This Phase 3 study only looked at those patients suffering from episodic migraines, which are defined by the occurrence of a migraine on anywhere between one to 14 days per month.
The earlier Phase 2 trial tested AMG 334 in chronic migraine, which is less common and is characterized by at least 15 days with a headache per month. In that study, treatment led to an average 6.6-day reduction from baseline, again surpassing the 4.2-day decline seen in the placebo arm.
Another Phase 3 study evaluating the drug over 6 months rather than 3 months is expected to wrap up by the end of the year.
Teva is also in Phase 3 testing of its CGRP drug TEV-48125, while Alder's candidate recently hits its endpoint in a Phase 2b study.
Lilly has two Phase 3 studies of its drug galcanezumab currently ongoing in cluster headache and migraine prevention.
AMG 334 could be destined for big things, if the positive data seen in recent readouts leads to an approval. Jefferies, an investment firm, projects peak annual sales of $1 billion, assuming a 2017 filing, according to a note from equity analyst Jeffrey Holford.
Amgen and Novartis are jointly developing AMG 334, but Amgen has retained commercialization rights in the U.S., Canada and Japan. Novartis would market the drug in Europe and the rest of the world, if approved.
- Novartis Statement
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