New Clinical and Real-World Data Evaluating Efficacy of AJOVY® (fremanezumab-vfrm) Injection Presented at 2021 American Headache Society (AHS) Annual Meeting

Rhea-AI Summary

Teva Pharmaceuticals announced new data on AJOVY (fremanezumab) at the American Headache Society meeting, highlighting clinical and real-world efficacy for treating migraines. The presentation includes a 12-month extension study from the HALO clinical program, addressing both episodic and chronic migraines. Key findings show that patients experienced statistically significant reductions in migraine days, with notable results among those with comorbid conditions like depression and anxiety. AJOVY remains the only long-acting anti-CGRP injection approved in the US.

Positive

• The presentation at the AHS meeting demonstrates strong long-term efficacy of AJOVY for migraine treatment, with statistically significant reductions in migraine days.
• Real-world studies showed significant decreases in antidepressant use among patients with comorbid depression, indicating AJOVY's broader health benefits.
• AJOVY's unique dosing options (quarterly and monthly) cater to diverse patient needs, enhancing its market appeal.

Negative

• None.

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data from clinical and real-world analyses examining the efficacy of AJOVY^® (fremanezumab-vfrm) for the treatment of migraine, which is being presented at the American Headache Society (AHS) annual meeting, taking place virtually on June 3-6.

AJOVY data presentations span 11 posters and include a 12-month extension study from the HALO clinical program, which examines the long-term response of episodic migraine (EM) and chronic migraine (CM) patients treated with AJOVY.

“Forty percent of migraine patients could benefit from preventive therapies, however only about 13 percent of these patients are currently on preventive treatment. ^1,2 It’s important for patients and the healthcare community to know their treatment options in managing their disease,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs, Teva. “In order to help address this unmet need, we’re continuing to explore AJOVY in clinical and real-world settings. We’re pleased to see the data presented at AHS is examining subgroups of patients who may experience fewer migraine days with AJOVY.”

Other presentations include an analysis of the real-world impact of AJOVY on migraine patients with comorbid depression, anxiety or hypertension (HTN), and a Phase 3b open label extension study from the FOCUS clinical program of AJOVY treatment in migraine patients with inadequate response to multiple prior migraine preventive medication classes.

“These analyses and extension studies of our landmark HALO and FOCUS clinical programs, evaluating AJOVY over the course of 15 months and the efficacy in patients who’ve failed prior treatments, reinforce the potential AJOVY can have for patients living with migraine,” said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Therapeutic Area Lead for Migraine & Headache, Teva.

AJOVY is the first and only long-acting anti-CGRP subcutaneous injection approved in the US for the preventive treatment of migraine in adults that offers both quarterly and monthly dosing options.^3+±

Clinically Meaningful Responses to Fremanezumab Treatment in Episodic and Chronic Migraine Over the Course of 15 Months

Patients who completed the Phase 3 HALO EM and CM clinical trial, along with new patients, entered the HALO long-term study. A post-hoc analysis examined efficacy of AJOVY for reduction from baseline in monthly migraine days, duration of this response, and the proportion of participants with sustained response over the course of 15 months. Data do not include p-values. Both quarterly and monthly doses of fremanezumab exhibited clinically meaningful response in EM and CM, based on the reduction from baseline in MMD, the duration of this response, and the proportion of participants with response over up to 15 months.

	Episodic Migraine Participants		Chronic Migraine Participants
Dosing	Quarterly	Monthly	Quarterly	Monthly
Mean time to achieve ≥50% response	1.7 months	1.7 months	2.5 months	2.3 months
Mean time to achieve ≥75% response	2.4 months	2.7 months	3.1 months	3.1 months
Avg. duration of time that ≥50% response was maintained	5.4 months	5.1 months	5.0 months	5.2 months
Avg. duration of time that ≥75% response was maintained	3.8 months	3.8 months	2.8 months	3.9
Proportion of participants who had sustained ≥50% response over 12 months of treatment	50%	45%	48%	53%
Proportion of participants who had sustained ≥75% response over 12 months of treatment	31%	36%	38%	29%

This poster, Lasting Clinically Meaningful Responses to Fremanezumab Treatment in Episodic and Chronic Migraine Over the Course of 15 Months, is included in the online program.

Real-World Impact of AJOVY Use on Clinical Outcomes Among Migraine Patients With Comorbid Depression, Anxiety or Hypertension

An analysis from the Veradigm Health Insights Database evaluated the real-world impact of AJOVY in migraine patients with comorbid depression, anxiety or hypertension (HTN). Patients were included if they were ≥18 years old, had ≥1 migraine diagnosis during the study period from January 1, 2014–June 30, 2019, and had a medication record for AJOVY on or after diagnosis during the identification period (September 1, 2018–December 31, 2018). The number of patients with migraine in the depression, anxiety and HTN subgroups were 172, 180 and 142 respectively. The following outcomes were recorded:

• Depression subgroup: statistically significant reductions were observed in the follow-up period in the proportion of patients with depression (−12.2% [P = 0.003]) and in the number of antidepressant prescriptions used (−0.2 [P = 0.008]).
• Comorbid anxiety subgroup:statistically significant reductions were observed in the follow up period in the proportion of patients with anxiety (−7.8% [P = 0.037]), while a non-significant decrease was observed in the number of anxiolytic prescriptions used (−0.1 [P = 0.182]).
• HTN subgroup: Out of 142 patients, 80 of them reported a mean SBP of 127.32 mmHg and a mean DBP of 78.43 mmHg during the baseline period. Non-significant reductions in SBP and DBP were observed during the follow-up period (−0.34 and −0.59, respectively [P = 0.8374 and 0.5624, respectively]).

This real-world study demonstrates a statistically significant decrease in anti-depressant prescription use for patients with comorbid depression and in anxiolytic prescription use for patients with comorbid anxiety. Among patients with comorbid HTN, no increases were observed in mean SBP and DBP levels with AJOVY treatment.

This poster, Real-World Impact of AJOVY Use on Clinical Outcomes Among Migraine Patients With Comorbid Depression, Anxiety or Hypertension, is included in the online program.

Fremanezumab Treatment in Chronic and Episodic Migraine Patients With Inadequate Response to 2-4 Prior Classes of Migraine Preventive Medications

The efficacy of fremanezumab has been demonstrated in adults with EM and CM who’ve had inadequate response to 2-4 prior classes of migraine preventive medications in the 12-week, double-blind, placebo-controlled period (DBP) of the Phase 3b FOCUS study. All patients who completed the DBP entered the open label extension (OLE) and received monthly doses of fremanezumab (225 mg) or 3 quarterly doses (month 1/2/3 at 675 mg). Patients with a sustained response, based on a reduction from baseline of ≥50% or ≥75% in monthly migraine days, during the 12-week DBP who maintained that response throughout the 12-week OLE (from month 4 to 6) were evaluated. Of the 838 patients randomized, 807 completed the double-blind period and entered the OLE.

With monthly fremanezumab treatment during the OLE, 60% (71/119) of patients with a ≥50% sustained response during the DBP and 38% (10/26) of patients with a ≥75% sustained response during the DBP maintained that response throughout the 12-week OLE. Among patients with a ≥50% response at the start of the OLE, 65% (218/335) maintained that response throughout the OLE, while among patients with a ≥75% response at the start of the OLE, 42% (66/158) maintained that response throughout the OLE.

The fremanezumab analyses highlight data on sustained clinically meaningful responses over 6 months in patients with EM or CM and inadequate response to multiple prior migraine preventive medication classes.

This poster, Evidence of Maintained Efficacy for Fremanezumab Treatment in Chronic and Episodic Migraine Patients With Inadequate Response to 2-4 Prior Classes of Migraine Preventive Medications, is included in the online program.

This year’s annual AHS meeting is fully virtual. Data presentations can be accessed by registering for the meeting.

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.

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 regarding 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:

• the commercial success of AJOVY;
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; 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, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• our business and operations in general, including: uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; 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; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; 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; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
• compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities (including as a result of potential tax reform in the United States); and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in this press release and in our Quarterly Report on Form 10-Q for the first quarter of 2021 and in our Annual Report on Form 10-K for the year ended December 31, 2020, 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.

References

1. Lipton RB, et al. Neurology 2007;68:343–49
2. Vander Pluym J, et al. Headache 2016;56:1335–43
3. AJOVY^® (fremanezumab-vfrm) injection, for subcutaneous use [prescribing information]. Teva Pharmaceuticals USA, Inc.: North Wales, PA; 2020.

⁺ “Long-acting” defined as efficacy measured over a 12-week period following a 675 mg (225 mg x 3) SC dose.^2
± 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210603005207/en/

FAQ

What new data did Teva announce for AJOVY at the AHS meeting?

Teva announced new clinical and real-world data showing AJOVY's effectiveness in reducing migraine days, presented at the American Headache Society meeting.

How effective is AJOVY for chronic and episodic migraines?

AJOVY has shown statistically significant reductions in migraine days for both chronic and episodic migraine patients, based on the HALO clinical study.

What were the results for AJOVY in patients with comorbid depression?

In patients with comorbid depression, there was a statistically significant reduction in the proportion of patients with depression and in antidepressant prescriptions.

When is the AHS annual meeting taking place?

The American Headache Society annual meeting is taking place virtually from June 3-6.

What is the dosing schedule for AJOVY?

AJOVY is administered as a subcutaneous injection with options for both monthly and quarterly dosing.