Amgen (NASDAQ: [[ticker:AMGN]]) and Teva Pharmaceutical (NYSE: [[ticker:TEVA]]) this afternoon are providing the most detailed look yet at two drugs in an emerging class of medicines meant to prevent migraine headaches, rather than just quell their symptoms.
While the data for the two drugs, called erenumab (Aimovig, from Amgen and partner Novartis) and fremanezumab (from Teva), appear positive, some doctors expressed concern that a potentially high price tag will make them unaffordable for many patients who desperately need them.
Two papers published in the New England Journal of Medicine detailed the results from a 955-patient Phase 3 study of erenumab called STRIVE and a 1,130-patient Phase 3 trial called HALO. The studies tested the respective migraine drugs in people who have either episodic migraines, meaning they suffer from migraines up to 14 days per month, or chronic migraines, meaning 15 days or more each month.
In the STRIVE study, participants with episodic migraines took two different erenumab doses or a placebo for six months. Patients who suffered a migraine an average of 8.3 days per month at the start of the study saw those days decline an average of 3.2 days on a low dose and 3.7 days on a high dose, compared to an average 1.8 day decline for placebo patients.
The most common side effects were mild, and there was virtually no difference in dropouts from the study between the erenumab and placebo arms.
In Teva’s HALO study, patients with chronic migraines took either a quarterly or monthly dose of fremanezumab or a placebo, and were assessed after three months. The results: a 4.3-day reduction in average migraine days per month for those on a quarterly dose and a 4.6-day decrease for those on a monthly dose. Patients on placebo had 2.5 fewer migraine days per month at the end of the study. The quarterly group started out with 13.2 migraine days per month, compared to 12.8 days for the monthly group and 13.3 days for placebo patients.
Side effects were mostly mild to moderate, according to the paper, with the most common being pain from the injection.
When asked about the erenumab results specifically, STRIVE lead investigator Peter Goadsby, a professor of neurology at King’s College London, said: “This is a big deal. This is an effective therapy that is well tolerated.”
Amgen and Teva have each run two successful Phase 3 studies on their respective drugs. Each company has previously provided a snapshot of their data. In November 2016, Amgen touted success and simultaneously announced it would ask the FDA for approval of erenumab. The agency is expected to make a decision by May 17, 2018. Teva reported success in its chronic migraine study in May and filed for FDA approval of fremanezumab in October.
Also included in the NEJM papers this afternoon is information on secondary measures. New details from the STRIVE study include
