Teva to Present Data at the 2023 American Headache Society Annual Scientific Meeting Demonstrating AJOVY® (fremanezumab-vfrm) Injection Significantly Reduced Migraine and Depression Symptoms in Patients

By: Teva Pharmaceutical Industries Limited via Business Wire

June 15, 2023 at 08:00 AM EDT

Six abstracts to be presented highlighting results of AJOVY preventive treatment in patients with migraine
Oral presentation will feature data from the UNITE study showing that AJOVY significantly reduced migraine days and depression symptoms in patients with migraine and major depressive disorder
Findings on AJOVY real-world benefits and potential cost savings will also be presented

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that six abstracts revealing benefits of AJOVY (fremanezumab-vfrm) injection in patients with migraine will be presented at the 2023 American Headache Society (AHS) Annual Scientific Meeting, held June 15-18 in Austin, Texas.

Featured data will include an oral presentation of the Phase 4 UNITE randomized clinical study, investigating the efficacy and safety of AJOVY for preventive treatment in patients with migraine and comorbid major depressive disorder. Results showed that treatment with AJOVY was associated with statistically significant reductions in migraine days as well as reductions in symptoms of depression (HAMD-17 and PHQ-9 scores) over 12 weeks in patients with migraine and major depressive disorder.

“Patients who suffer from migraine and mental health disorders such as depression face a greater burden than those suffering from only one disease, and have higher risks for medication overuse, poorer quality of life and greater disability if untreated,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “The data we are presenting at AHS provide further insights into the potential efficacy, safety, and quality of life benefits of AJOVY for people with migraine and major depressive disorder.”

Additional presentations at AHS will include:

Health economics and outcomes research (HEOR) analyses examining the health care resource use pattern during the individual AJOVY treatment cycle and modeling potential cost impact associated with early initiation of AJOVY in the treatment pathway; and
Findings from the FINESSE study, a real-world, prospective, observational study to evaluate the effectiveness of AJOVY in patients with chronic and episodic migraine, including those for whom another calcitonin gene-related peptide (CGRP) pathway monoclonal antibody has failed.

The 2023 AHS Annual Scientific Meeting is being offered both in-person and virtually. Data presentations can be accessed by registering for the meeting.

The full set of Teva-sponsored AJOVY data to be presented includes:

UNITE

UNITE was a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study followed by a 12-week open-label extension (OLE) period. The study aimed to evaluate the efficacy and safety of AJOVY in adults with migraine and major depressive disorder. Patients were randomized 1:1 to receive 225 mg subcutaneous monthly AJOVY or matched placebo for 12 weeks.

The primary endpoint was the mean change in average number of monthly migraine days from baseline to Week 12 after the first dose of the study drug. Secondary efficacy endpoints included the proportion of patients achieving ≥50% reduction in major depressive disorder from baseline to Week 12.

The UNITE presentations at AHS will include:

P-231 Efficacy of fremanezumab treatment in reducing monthly migraine days in patients with migraine and major depressive disorder: results from the UNITE study

Presentation type: Poster (de novo)

Session: Friday Midday Exhibits and Posters

Date/Time: June 16, 2023, 12:35-1:50 PM CT

IO-05 Efficacy of fremanezumab in reducing depression in patients with migraine and major depressive disorder: results of the UNITE study

Presentation type: Oral

Session: Industry-Submitted Abstracts

Date/Time: June 17, 2023, 8:10-8:20 AM CT

P-232 Impact of fremanezumab treatment on disability outcomes in patients with migraine and major depressive disorder: results of the UNITE study

Presentation type: Poster (de novo)

Session: Saturday Midday Exhibits and Posters

Date/Time: June 17, 2023, 12:45-2:00 PM CT

HEOR Analyses

Results from two analyses will be presented: an economic modeling analysis which estimated potential cost savings associated with use of AJOVY earlier in the treatment cycle; and a real-world database (administrative claims) analysis which examined health care resource use (HCRU) during individual AJOVY treatment cycles to determine if there was an indication of a wearing-off effect with AJOVY.

The two HEOR presentations at AHS will include:

P-107 Initiation of fremanezumab earlier in the treatment cycle may result in cost savings to payors in the United States

Presentation type: Poster (encore)

Session: Friday Midday Exhibits and Posters

Date/Time: June 16, 2023, 12:35-1:50 PM CT

P-130 No 'wearing-off effect' seen with fremanezumab in the real‑world: a retrospective, claims-based analysis of migraine-related healthcare resource and acute medication use

Presentation type: Poster (encore)

Session: Saturday Midday Exhibits and Posters

Date/Time: June 17, 2023, 12:45-2:00 PM CT

FINESSE

The FINESSE study is a 49-month (25-month recruitment and 24-month follow-up) multicenter, two-country (Germany/Austria) prospective observational study to evaluate the real-world effectiveness of AJOVY in patients with chronic and episodic migraine during routine clinical practice.

The primary endpoint is the proportion of patients reaching ≥ 50% reduction in the monthly average number of migraine days evaluated during the 6-month period after the first dose of AJOVY. Secondary endpoints of the study include changes from baseline in the monthly average number of migraine days, disability scores, and days of acute migraine medication use per month.

The FINESSE presentation at AHS will include:

P-162 Real-world effectiveness of fremanezumab in patients with migraine who switched from another mAb targeting the CGRP pathway (subgroup analysis from FINESSE)

Presentation type: Poster (encore)

Session: Saturday Midday Exhibits and Posters

Date/Time: June 17, 2023, 12:45-2:00 PM CT

About AJOVY (fremanezumab-vfrm) Injection

AJOVY is available as a 225 mg/1.5 mL single dose injection in a prefilled syringe or autoinjector with two dosing options – 225 mg administered monthly 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. AJOVY is now approved in 45 countries worldwide.

Indications and Usage

AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.

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. Reactions have included anaphylaxis and angioedema.

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. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.

Please click here for full U.S. Prescribing Information for AJOVY (fremanezumab-vfrm) injection.

About 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 innovative 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 innovative 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, 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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize competition for our innovative medicines, including AUSTEDO^®, AJOVY and COPAXONE^®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section 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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Teva to Present Data at the 2023 American Headache Society Annual Scientific Meeting Demonstrating AJOVY® (fremanezumab-vfrm) Injection Significantly Reduced Migraine and Depression Symptoms in Patients

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