TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced Otsuka Pharmaceutical Co., Ltd. has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for AJOVY® (fremanezumab) injection for the preventive treatment of migraine.
“This is an exciting milestone that delivers on our global mission to improve patients’ lives by advancing potential new treatment options,” said Gianfranco Nazzi, Executive Vice President, International Markets at Teva.“Driven by the aspiration to bring high-value products to patients, we are pleased to be one step closer to making AJOVY available as a treatment option to patients in Japan living with migraine.”
AJOVY is under development in Japan by Otsuka as part of a May 2017 exclusive license agreement for development and sales of AJOVY in Japan. Earlier this year, the two companies announced outcomes from two pivotal studies of AJOVY in Japan in patients with episodic and chronic migraine. The primary endpoints were achieved in both trials with clinical and statistical significance versus placebo. Statistically significant improvements versus placebo also were demonstrated for all secondary endpoints. AJOVY was well tolerated with a similar adverse events profile compared to placebo.
AJOVY is the first and only long-acting anti-CGRP subcutaneous injection approved in the US and EU that is designed for the preventive treatment of migraine and offers both quarterly and monthly dosing options.i,ii,iii
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 new drug application filing in Japan for AJOVY® (fremanezumab) injection, 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 Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, 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.
i AJOVY(fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.
ii “Long-acting” defined as efficacy measured over a 12-week period following a 675 mg (225 mg x 3) SC dose.
iii 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections.
Kevin C. Mannix (215) 591-8912
Ran Meir 972 (3) 926-7516
Grace Ann Arnold
972 (54) 888 5898
Source: Teva Pharmaceutical Industries Limited