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2018-09-21| Trials & Approvals

AJOVY™, Teva’s new migraine drug gets USFDA approval

by Rajaneesh K. Gopinath
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Just four months after Aimovig™ (erenumab), codeveloped by Amgen and Novartis, the migraine community rejoices in the approval of yet another injectable migraine drug.
By Rajaneesh K Gopinath

Migraine is a neurological disorder caused by the release of inflammatory substances in the brain that manifests as severe headaches, accompanied by nausea and vomiting. One of the proteins that causes migraine is the calcitonin gene-related peptide (CGRP). On September 14th, Teva Pharmaceutical Industries Ltd announced the approval of their injectable drug, AJOVY™ (fremanezumab-vfrm) by the United States Food and Drug Administration (USFDA). The drug is a humanized monoclonal antibody that binds to CGRP, effectively obstructing the ligand from binding to its receptor and blocking its activity in the process. On the contrary, Aimovig targets CGRP receptor, rather than the ligand. AJOVY™ now becomes the second anti-CGRP treatment after Aimovig to be approved by the FDA for prevention of migraine in adults.

AJOVY™ is approved only for subcutaneous use and two recommended dosing options are currently available for patients; a 225 mg (monthly), or 675 mg every 3 months (quarterly), which is administered as three consecutive doses of 225 mg each. The efficacy of the drug was evaluated as a preventive treatment of episodic or chronic migraine in two multicenter, randomized Phase III, placebo-controlled clinical trials that enrolled patients with migraine. 662 patients received AJOVY™ 225 mg (monthly) for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY™ 675 mg (quarterly) for 12 weeks. In these trials, patients experienced a reduction in monthly migraine days. The most common adverse reactions were injection site reactions.

Headquartered in Israel, Teva has production and research facilities all around the globe. Their phase III trials of AJOVY™ were conducted in early 2017 and the application for FDA approval was submitted last October. Currently, AJOVY™ is priced at $575 per monthly dose and $1,725 per quarterly dose.

References
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761089s000lbl.pdf

2. https://www.drugs.com/history/ajovy.html

 

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