The FDA approved the Teva Pharmaceutical drug, just months after its phase 3 program for headache clusters was discontinued.
The US Food and Drug Administration (FDA) has approved fremanezumab (Ajovy) for the preventive treatment of migraine in adults.
The Teva Pharmaceuticals drug becomes the second in its class of calcitonin gene-related peptide (CGRP) inhibitors approved by the FDA to prevent migraines, following erenumab (Aimovig) in May of this year.
In a pivotal 12-week trial published in the New England Journal of Medicine last year, 1130 patients with chronic migraines were randomized 1:1:1 to receive either quarterly (675 mg) or monthly (675 mg baseline, 225 mg at weeks 4 and 8) subcutaneous injections of the inhibitor, or placebo. Investigators reported a reduction in the average rate of headache days per month at 4.3± 0.3 with fremanezumab quarterly, 4.6 ± 0.3 with monthly administration, and 2.5 ± 0.3 with placebo injections.
In an interview with MD Magazine at the Annual Academy of Neurology Meeting in Los Angeles this May, Stephen D. Silberstein, MD, director of the Jefferson Headache Center and professor at Thomas Jefferson University, said CGRP inhibitors have arrived as a major influx of good news in both migraine treatment and prevention.
“By taking a drug with a known method of action that works prevention, this drug will have a paradoxical effect of, ‘the more you take, the less headaches you will have’,” Silberstein said. “Not only is it safe and effective—it’s anti-rebound headache.”
Silberstein noted that there are no significant adverse events associated with this current class of CGRP inhibitors, while previous drugs in the same class had a history of liver function complications.
Fremanezumab had previously made news this June, when Teva announced altered plans for its clinical development for the indicated treatment of chronic cluster headache. The company stated its primary endpoint to the ENFORCE phase 3 program would not be met, and that the long-term safety examination of the 600-patient, 68-week trial would be discontinued.
At the time of the announcement, Tushar Shah, MD, senior vice president and head of Global Specialty Clinical Development for Teva, remained optimistic for fremanezumab’s potential as a beneficial therapy beyond migraine indication.