Teva presents latest data on AJOVY® ▼ (fremanezumab) at EHF Congress

July 09, 2020

AMSTERDAM, NETHERLANDS - Teva Pharmaceutical Europe B.V. has presented results from a pooled analysis of three randomized, double-blind, placebo-controlled Phase 3 studies assessing AJOVY® ▼ (fremanezumab), indicated for the preventative treatment of migraine in adults, which demonstrate clinically significant reductions in headache and migraine-related disability in the majority of patients studied.

The findings, presented at the 14th European Headache Federation (EHF) Congress, show that by comparison to placebo, individuals receiving fremanezumab treatment experienced a downward shift in disability severity, as defined by the validated HIT-6 and MIDAS assessment tools. At baseline, 87-89 per cent of patients had severe impact on HIT-6 and 74-75 per cent of patients had severe disability on MIDAS. In this analysis, the proportion of patients experiencing a downward shift of between 1 and 3 categories in severity of headache impact on HIT-6 was significantly greater than placebo with both doses of fremanezumab (47 to 50 per cent) versus placebo (33 per cent). Similarly, the number of patients experiencing a downward shift of 1, 2 or 3 grades in disability severity according to MIDAS scores was significantly greater with fremanezumab (55 to 58 per cent) versus placebo (40 per cent).

A parallel analysis assessed clinically meaningful improvements in HIT-6 and MIDAS scores in line with a recent American Headache Society (AHS) consensus statement. According to AHS, a ? 5 point reduction on HIT-6 is clinically meaningful, and this was achieved by 53-55 per cent of fremanezumab-treated patients versus 39 per cent of placebo patients. For MIDAS, AHS considers a ? 5 point reduction for patients with a baseline score of 11-20 or a ? 30% reduction for those with a baseline score > 20 to be clinically meaningful. The former was achieved by 70-71 per cent of fremanezumab treated patients versus 49 per cent of placebo patients, while the latter was achieved by 69-79 per cent of fremanezumab treated patients versus 58 per cent of placebo patients.

Collectively, the pooled analyses indicate that fremanezumab therapy in both quarterly and monthly regimens may result in clinically meaningful improvements particularly for patients with difficult-to-treat migraine, which can be debilitating and severely impact the quality of life for individuals.

"The personal impact of both episodic and chronic migraine cannot be underestimated," said Joshua M. Cohen, MD, MPH, FAHS, Sr. Director, Therapeutic Area Lead Migraine & Headache, Global Medical Affairs, Teva Pharmaceutical Europe B.V. "A continual need exists for new therapies which can help and support those affected and help individuals maintain a normal life where ability to work, be productive and look after families are not heavily compromised. These new analyses add to the positive data on fremanezumab and suggest it plays an important role in limiting and mitigating disability at several levels of severity, particularly for individuals who are finding their migraine difficult to treat and manage."

An additional study assessing long-term efficacy of fremanezumab in episodic and chronic migraine, also presented at the Congress, showed that over six to 15 months of long-term treatment, patients with difficult-to-treat migraine experienced progressive improvements in migraine days, with increasing numbers of patients achieving clinically meaningful response rates.

Migraine is a debilitating neurological disease that causes recurrent episodes of pain lasting 4-72 hours, often accompanied by nausea, vomiting, photophobia, phonophobia and a variety of other debilitating symptoms.

The pooled analyses follow primary results from the Phase FOCUS study in which fremanezumab was shown to significantly reduce the number of migraine and headache days of at least moderate severity as early as the first week of treatment in adult patients who had responded inadequately to two or more classes of migraine preventive therapy when compared to placebo. The proportion of patients experiencing a 50 percent or higher reduction of migraine days was also significantly greater than placebo. The incidence of adverse events (AEs) including AEs leading to treatment discontinuation and serious AEs was shown to be low and consistent with placebo.

The data presentations at EHF 2020 follow findings from the Teva-sponsored research project Beyond Migraine: The Real You survey of over 7,500 people living with the disease in Europe. The survey conducted across 10 European countries found that people living with migraine were struggling in how to better support themselves or advocate for improved disease management. The broader survey results went on to explore the often-devastating impact of migraine on all aspects of a patient's life, ranging from their relationships, work life, social life and education. Of those patients who were receiving treatment from their HCP, almost 8 in 10 (77%) said that their treating doctor took their disease very seriously, but 30% felt their doctor was not sufficiently informed on the latest migraine treatments.2 One in 4 people said they would like to be more involved in decisions about their treatment.2

"While I have seen significant improvements in migraine management over recent decades, the survey data highlights the need for more work to be done to raise awareness, increase knowledge and continue to integrate a faster migraine diagnosis process" said Elena Ruiz de la Torre, Executive Director, European Migraine and Headache Alliance (EMHA).

Information for Europe about AJOVY® ▼ (fremanezumab) 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.

AJOVY is available as a 225 mg/1.5 mL 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), which is 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. The AJOVY autoinjector has been approved by the FDA and is available in the U.S. In addition to the U.S., the AJOVY autoinjector has been approved by the EMA and is currently available in Germany and should soon be available in other select European markets.
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About the 'Beyond Migraine: The Real You survey2About Teva

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 http://www.tevapharm.com.

Ketchum UK

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