FDA approves Ajovy（fremanezumab-vfrm ）

Fremanezumab-vfrm (hereafter referred to as fremanezumab) [AJOVY™] is a fully humanized monoclonal antibody (IgG2Δa) developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine). Its use has been associated with significant reductions in migraine frequency, the requirement for acute headache medication use and headache-related disability compared with placebo in multinational, phase III studies, and in September 2018 fremanezumab was approved by the US FDA for the preventive treatment of migraine in adults. A regulatory assessment for fremanezumab as a preventive treatment of migraine in adults is underway in the EU. Fremanezumab is also undergoing phase III development for the preventive treatment of cluster headache (although a phase III chronic cluster headache study has been suspended due to the results of a prespecified futility analysis) and phase II development for the preventive treatment of post-traumatic headache disorder. This article summarizes the milestones in the development of fremanezumab leading to this first approval in the USA for the preventive treatment of migraine in adults.   

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

AJOVY is a drug used for the preventive treatment of migraine in adults.

A migraine is a type of headache that can be associated with nausea, vomiting, and sensitivity to light, sound, or smell.

How is this drug used?

AJOVY is an injection given under the skin (subcutaneous). Two dosing options are available for AJOVY (one subcutaneous injection once a month or three subcutaneous injections once every three months).

What are the benefits of this drug?

Over the three-month treatment period, patients treated with AJOVY experienced fewer days of migraine headaches in comparison to patients who received placebo treatment.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: AJOVY works similarly in both men and women.
• Race: The majority of patients were White. The number of patients in other races were limited; therefore, differences in how AJOVY worked among races could not be determined.
• Age: The majority of patients were less than 65 years of age; therefore, differences in how AJOVY worked among age groups could not be determined.