New Real-World Data Evaluating AJOVY® (fremanezumab-vfrm) Injection Use in Patients With Migraine Presented at 2022 American Headache Society Annual Meeting

By: Teva Pharmaceutical Industries Limited via Business Wire

June 09, 2022 at 08:00 AM EDT

Findings from a retrospective U.S. electronic medical record study on use of AJOVY and concomitant gepants for preventive migraine treatment reported in a late-breaking poster presentation

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a U.S. retrospective study examining real-world concomitant use of AJOVY (fremanezumab-vfrm) injection and gepants in the prevention and acute treatment of migraine. The data showing a reduction in monthly migraine days with the treatment combination were presented as a late-breaking poster during the 2022 American Headache Society (AHS) Annual Meeting held June 9-12, 2022, in Denver, Colorado.

Data presentations at AHS included eight abstracts examining real-world use of AJOVY across different patient populations and clinical circumstances. In an additional poster presentation, results of a subgroup analysis from the Phase 3b FOCUS study examining the use of AJOVY in patients with difficult-to-treat migraine and comorbid obesity were reported. The real-world effectiveness of fremanezumab in patients with refractory migraine from a US tertiary headache center who switched from erenumab study was also highlighted.

“The breadth of real-world evidence presented at this year’s AHS meeting across different patient populations and practice settings underscores the value of AJOVY in helping to manage this disabling neurological disease,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “As the migraine treatment landscape continues to advance, these data provide important insights about AJOVY in real-world settings and its use as a migraine preventive treatment across a spectrum of patients.”

Real-World Effectiveness and Tolerability of Fremanezumab for the Preventive Treatment of Migraine in Patients Using Concomitant Gepants for Acute Treatment in a US Neurology Practice

The US retrospective chart review study examined data from electronic medical records of 55 adult patients (age 18 and older) from the Dent Neurologic Institute, a multi-location practice in New York, who used AJOVY for preventive migraine treatment and concomitant gepants for acute migraine treatment between January 1, 2020 and May 1, 2021. Data were collected on patients with chronic and episodic migraine. Patients were on a gepant therapy for one or more months pre- and post-initiation of AJOVY as add-on therapy. Patients with three or more measurements of monthly migraine days (MMD) were included in the analysis: one at the pre-index date (gepant initiation), one at index (AJOVY initiation), and one at the post-index period (gepant + AJOVY).

At the time of AJOVY initiation, patients had an average (standard deviation) of 15.8 (7.4) MMD. The average time from the index date to the last visit was 9.4 (4.5) months. The average change in MMD from the index to the post-index date was -6.5 (1.0) days, representing a 41.1% reduction. Five patients (9.1%) had adverse events post-index; 3 injection site reactions, 1 uveitis and 1 upset stomach.

“Millions of people suffer from migraine and its debilitating effects, and finding the right treatment combination can be challenging. Different treatment approaches can be used synergistically, but given that these are relatively new treatments, real-world data on the concomitant use of AJOVY and gepants is limited,” said Jennifer McVige, M.D., MA, Attending Neurologist, DENT Neurologic Institute in Amherst, NY. “This study provides some of the first evidence that this treatment combination resulted in reductions in monthly migraine days. Continued investigation into this treatment approach is warranted.”

About AJOVY (fremanezumanb-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. 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.

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 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, 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 commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, 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 uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; 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 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, 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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New Real-World Data Evaluating AJOVY® (fremanezumab-vfrm) Injection Use in Patients With Migraine Presented at 2022 American Headache Society Annual Meeting

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