Teva Confirms Efficacy and Safety of AJOVY (fremanezumab) for the Prevention of Migraine With Results from Phase 3 Trial in China - Seite 2

"For the many millions of migraine patients in China,¹ there is a need for preventive treatment options that may help reduce the number of migraine days they experience and support the alleviation of the incapacitating symptoms migraine can cause,” said Shengyuan Yu, MD, PhD, Director and Professor, Department of Neurology, Chinese PLA General Hospital. "These Phase 3 data indicate that fremanezumab has the potential to significantly improve life quality of the patients with migraine in China.”

In the study, AJOVY was safe and well tolerated with no safety signals observed. The most common treatment-related (≥5%) AEs were injection site reactions.

Additional findings from this study are planned for presentation at a medical meeting later this year.

About AJOVY Phase 3 Study in China

This multicenter, randomized, double-blind, placebo-controlled study is evaluating the efficacy, safety and tolerability of fremanezumab injection for subcutaneous use as a treatment in patients (ages 18-70 years) with episodic or chronic migraine vs placebo. The study enrolled 365 patients who were randomized to receive a subcutaneous injection of fremanezumab once-monthly or once-quarterly, or placebo in a 1:1:2 ratio. The primary objective is to demonstrate the efficacy of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections to adult Chinese participants with migraine. The secondary objectives are to further demonstrate the efficacy of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections and to evaluate the safety and tolerability of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections. The study consists of a screening visit, a baseline period (4 weeks), a 12-week double-blind treatment period, a 12-week open-label treatment period when all patients receive 225mg of AJOVY monthly, and a follow-up period lasting 3 months after the last dose of treatment. The open label phase of the trial is still ongoing.

About AJOVY▼ (fremanezumab-vfrm) injection

AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver.