The US FDA has approved a new humanised monoclonal antibody for migraine prevention in adults. Fremanezumab-vfrm – under the brand name AJOVYTM (Teva Pharmaceuticals) – prevents the interaction between calcitonin gene-related peptide (CGRP) and its receptor by binding the peptide ligand. While the first FDA-approved anti-CGRP injectable was announced in May of this year (erenumab), AJOVY is the first to be available for quarterly and monthly dosing. As a self-injectable, it can be easily administered by the patient at home.
AJOVY’s approval came off the back of two phase III, placebo-controlled trials evaluating AJOVY monotherapy versus combination therapy with oral preventative drugs in migraine sufferers. The first trial (875 patients) randomised episodic migraine patients to AJOVY 675 mg quarterly, 225 mg monthly, or placebo monthly for a total study period of 3 months. The quarterly and monthly AJOVY arms showed statistically significant reduction in the monthly average of migraine days (-3.4 and -3.7 days, respectively) over the study period, compared to placebo (-2.2 days).
The second study focused on 1,130 patients with chronic migraine histories, again over 3 months. Dosing here was 675 mg followed by 225 mg monthly, 675 mg every quarter, or monthly placebo. Once again, a reduction in migraine days was seen in the monthly/quarterly groups (-4.6/-4.3 days, respectively), compared to placebo (-2.5 days). The most common adverse events were injection-site reactions.
“About 40% of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated,” noted Stephen Silberstein, Director of the Jefferson Headache Center at Thomas Jefferson University Hospitals, Philadelphia, PA, USA, in a Teva Pharmaceuticals press release. “I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”
AJOVY will be supplied as a 225 mg/1.5 mL strength, preservative-free, single-dose prefilled syringe, and is anticipated to launch around the end of September.