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Three late breakers, one oral presentation and 27 posters showcase AJOVY as a preventive treatment for migraine
JERUSALEM & PARSIPPANY, N.J.--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Company will present 31 scientific abstracts for AJOVY® (fremanezumab-vfrm) injection at the 61st Annual Scientific Meeting of the American Headache Society, taking place in Philadelphia from July 11-14, 2019. AJOVY is indicated for the preventive treatment of migraine in adults.
“Migraine continues to be a difficult to treat disease and as the migraine treatment landscape evolves, we remain committed to improving the lives of patients,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva. “We are pleased to be presenting 31 posters and presentations at AHS this year, and our presence underscores Teva’s ongoing focus on addressing the treatment challenges that migraine patients face.”
The data to be presented include findings from the FOCUS study, a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy and safety of quarterly and monthly treatment with AJOVY, compared to placebo. The FOCUS study is the largest study to date in patients who inadequately responded to 2-4 classes of preventive migraine treatments, and is the first study of its type to be conducted in chronic as well as episodic migraine patients. Of note, this year’s AHS meeting is the first time that FOCUS data will be presented at a U.S. meeting.
Additionally, two late-breaking poster presentations will detail findings from a web-based patient survey following completion of an AJOVY 1-year extension study.
Teva-sponsored data to be presented includes:
Late-Breaking Poster Presentations:
AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.
Important Safety Information about AJOVY®
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 Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.
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 35,000 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 Fremanezumab (commercialized as AJOVY®), 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 Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." 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.
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Source: Teva Pharmaceutical Industries Ltd.