Fremanezumab (Ajovy) was , said drugmaker Teva Pharmaceuticals.
It becomes the second migraine drug targeting calcitonin gene-related peptide (CGRP) to reach the market.
A fully humanized monoclonal antibody, binds to the CGRP ligand and blocks its binding to the receptor. The first drug approved in this class, erenumab (Aimovig), binds to the CGRP receptor and was approved in May.
"About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated," said Stephen Silberstein, MD, of Thomas Jefferson University Hospital and lead investigator of the fremanezumab phase III trials, in a Teva statement. "I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days."
Fremanezumab is the first anti-CGRP treatment for migraine prevention with quarterly (675 mg) and monthly (225 mg) injectable dosing options. It was evaluated in two phase III, placebo-controlled trials: one of episodic migraine patients, the other of chronic migraine patients. Both groups saw a reduction in monthly migraine days over 12 weeks. The most common adverse events were injection-site reactions.
Preliminary results of a follow-up study showed that 1 year after starting fremanezumab treatment, chronic migraine patients continued to experience fewer headaches each month, but 10% to 12% of patients reported upper respiratory tract infections.
The fremanezumab clinical trials, like other CGRP antibody studies, "enrolled a group of participants who are not fully representative of patients most likely to receive the treatment in practice," observed Elizabeth Loder, MD, of Brigham and Women's Hospital in Boston, who was not involved in the research. "People who had failed two or more preventive medications or who had common comorbidities were excluded."
Fremanezumab will carry a wholesale price of $575 per monthly dose and $1,725 per quarterly dose. It should be available through retail and specialty pharmacies in approximately two weeks, drug maker Teva said.
The FDA originally was scheduled to rule in June on Teva's marketing application for fremanezumab, but agency officials told the company in May they would need another 3 months to complete the review, with no reason given publicly. In June, Teva also discontinued its study of fremanezumab in when a futility analysis showed the trial's endpoints most likely would not be met. That decision did not affect the trial of fremanezumab in , which is still underway.