Teva Pharmaceuticals has unveiled positive data from a Phase III study evaluating Ajovy (fremanezumab) for the prevention of migraines in Chinese adult patients.
Teva’s Ajovy is already approved to prevent migraines in adults in the US and Europe, receiving regulatory approval from the US Food and Drug Administration and the European Medicines Agency in 2018 and 2019 respectively.
The current Phase III trial enrolled 365 patients in China with episodic or chronic migraine. Half the patients were subcutaneously administered 225mg of Ajovy once monthly for three months or once-quarterly at 675mg; the other half received a placebo. Teva reported the trial achieved its primary endpoint and all secondary endpoints of efficacy and safety. Patients who took Ajovy demonstrated a reduction in the number of migraine days experienced per month, along with high efficacy during the first three months after the first use of the drug. The Israeli-based company reported a good safety profile.
Teva said it will announce additional findings at a medical meeting later this year but provided no information on regulatory plans for Ajovy in China.
Ajovy is a monoclonal antibody that works by attaching to the chemical messenger calcitonin gene-related peptide (CGRP), which contributes to the development of migraines while Ajovy prevents it from binding to target cells.
Ajovy has been increasing in popularity since its first regional approval four years ago. It is forecast to generate global sales of $773m by 2030, up from $434m in 2023, according to analysis by GlobalData.
GlobalData is the parent company of Clinical Trials Arena.
Also approved in the migraine prevention space is AbbVie’s Aquipta (atogepant), which is forecast to gain blockbuster status in 2026, according to GlobalData. By 2030, it is estimated to see sales of $1.5bn. On the same day as Teva’s announcement, Aquipta was recommended as an option on England’s NHS to qualifying patients living with chronic and episodic migraines.
Pfizer has developed a nasal spray for migraines, providing a fast-acting option for patients. Zavspret (zavegepant) was approved by the FDA in March 2023.
Eli Lilly’s Emgality (galcanezumab) is currently under regulatory review in China for migraine prevention. AffaMed has tied up commercialisation rights to the drug in the region if approved. Similar to Pfizer’s Zavspret, Emgality also uses a CGRP mechanism. Eli Lilly and Teva were involved in a patent dispute, with the American drugmaker eventually coming out on top.
Teva’s chief medical officer Eric Hughes said: “China has the largest migraine population worldwide, and Teva is committed to research on a global scale that helps address an unmet need where it exists and ensure that the role of treatment innovations like Ajovy are better understood.”
Ajovy has also demonstrated positive results from a Phase IV trial in patients with major depressive disorder.
