Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive results from two Phase 2/3 trials evaluating AJOVY® (fremanezumab) in patients in Japan. AJOVY is under development in Japan by Otsuka Pharmaceutical Co., Ltd. (Otsuka) as part of a May 2017 exclusive license agreement for development and sales of AJOVY in Japan.
“This study adds to the wealth of positive AJOVY data we have in patients globally,” said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache at Teva. “The annual prevalence of migraine in Japan is 8.4% of adults,1 so we are pleased to be one step closer to bringing AJOVY to patients in Japan who could benefit from a preventive treatment.”
Preliminary trial results indicated that primary endpoints were achieved with both clinical and statistical significance versus placebo for subjects with chronic migraine and episodic migraine, respectively. Statistically significant improvements versus placebo were also demonstrated for all secondary endpoints. AJOVY was well tolerated with a similar adverse events profile compared to placebo. Following additional analysis, more detailed results will be presented at upcoming medical congresses and publications. These are pivotal studies that will enable filing for Pharmaceuticals and Medical Devices Agency (PMDA) approval for marketing authorization.
AJOVY is the first and only anti-CGRP drug approved in the US and EU that is designed for the preventive treatment of migraine that offers both quarterly and monthly dosing options.
U.S. Important Safety Information about AJOVY® (fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.
Information for Europe about AJOVY® can be found here.
Adverse events should be reported.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.
Reporting forms and information can be found at https://www.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding FDA approval of AJOVY® (fremanezumab) injection Autoinjector, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Quarterly Reports on Form 10-Q for the first, second and third quarter of 2019 and in our Annual Report on Form 10-K for the year ended December 31, 2018, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Kevin C. Mannix
972 (3) 926-7516
972 (54) 888 5898