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TEVA PHARMACEUTICAL INDUSTRIES LIMITED

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Teva Pharmaceutical Industries : Late-Breaking Data at the International Headache Society & European Headache Federation Joint Congress 2021 Showed AJOVY® (fremanezumab-vfrm) Injection Reduced More Monthly Migraine Days in a Network Meta-Analysis Study with Atogepant and Rimegepant

09/08/2021 | 08:01am EDT

Study examined efficacy of AJOVY, atogepant and rimegepant in the prevention of episodic migraine

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a network meta-analysis examining the efficacy of AJOVY (fremanezumab-vfrm), atogepant and Nurtec® ODT (rimegepant) in the preventive treatment of episodic migraine (EM). This data will be presented as a late-breaker ePoster during the International Headache Society (IHS) and European Headache Federation (EHF) Joint Congress taking place virtually on Sept. 8-12, 2021.

AJOVY is the first and only long-acting (defined as efficacy measured over a 12-week period following a 675 mg [225 mg x 3] subcutaneous dose) anti-CGRP subcutaneous injection approved for the preventive treatment of migraine in adults with both quarterly and monthly dosing options.1+±

Migraine is a disabling chronic neurological disease that causes head pain and associated symptoms so severe that people often cannot function during an attack. Migraine reduces quality of life and disrupts the lives of those suffering from migraine and their ability to perform daily activities.2,1 It is among the top 10 causes of disability worldwide.2

“As migraine is so prevalent affecting one billion people worldwide3, it’s important for us to explore fremanezumab’s full treatment potential to ensure we’re offering patients an option to help prevent their migraine attacks,” said Matthias Mueller, MD MSc, VP Global Medical Affairs at Teva. “We’re pleased to see the migraine treatment landscape continue to advance, and these latest data provide clinicians with new insights into the impact of choosing a treatment option for each individual patient, reducing this migraine burden for patients.”

The meta-analysis indirectly assessed changes from baseline in monthly migraine days (MMD) and 50 percent reduction from baseline in MMD for patients receiving AJOVY, atogepant and rimegepant compared to placebo.

Additional retrospective post hoc analyses were conducted to understand migraine and headache frequency and severity for chronic migraine (CM) and EM patients who were treated with AJOVY. The analyses included patients who were initially enrolled in the Phase 3 HALO and FOCUS clinical programs. No determination of statistical significance can be made, and individual results may vary. No new safety signals were identified against the known safety profile of AJOVY.

Late-Breaker ePoster: Network Meta-analysis on Monthly Migraine Day Reductions with Fremanezumab, Rimegepant, and Atogepant in the Prevention of Episodic Migraine
This meta-analysis assessed relative efficacy for AJOVY monthly (MLY) and quarterly (QLY) dosing, atogepant daily (QD) and twice-daily (BID) dosing, and rimegepant every-other-day (QOD) dosing in the preventive treatment of EM.

Results observed in this analysis are as follows:

Pairwise Comparisons of the Change from Baseline in MMD at a 12-Week Follow-upa (Mean Difference [95% credible interval])

AJOVY MLY 225 mg

AJOVY QLY 675 mg

Versus…

−1.30 [−2.10, −0.51]

−1.02 [−1.86, −0.17]

Rimegepant 75 mg QOD

−1.00 [−1.65, −0.34]

−0.71 [−1.42, −0.01]

Atogepant 10 mg QD

−0.97 [−1.60, −0.35]

−0.69 [−1.37, −0.00b]

Atogepant 30 mg QD

−0.92 [−1.54, −0.30]

−0.64 [−1.32, 0.05]

Atogepant 60 mg QD

−0.52 [−1.50, 0.45]

−0.24 [−1.25, 0.78]

Atogepant 30 mg BID

−0.62 [−1.44, 0.21]

−0.33 [−1.20, 0.53]

Atogepant 60 mg BID

 

a1-12 weeks; 9-12 weeks for Rimegepant
bExact value with 3 decimal places: −0.004

The following poster presentations are also available as part of the virtual joint congress:

Poster: Time Gained with Long-term Fremanezumab Treatment in Patients with Chronic and Episodic Migraine
This post hoc analysis assessed the number of headache-free days (HFD) and migraine-free days (MFD) in patients using fremanezumab from a one-year extension study of the HALO program (HALO LTS). Patients were randomized one-to-one to receive quarterly or monthly dosing of fremanezumab.

Migraine-Free Days
It was observed that CM patients gained an average of 80 MFD over the course of one year in the quarterly dosing group (mean expected/actual migraine days [MD]: 214/134) and an average of 91 MFD (mean expected/actual MD: 214/124) in the monthly dosing group. For EM patients, the analysis observed patients in the quarterly dosing group gained an average of 65 MFD (mean expected/actual MD: 120/55) and patients in the monthly dosing group gained an average of 62 MFD (mean expected/actual MD: 119/57).

Headache-Free Days
It was observed that CM patients gained an average of 78 HFD over the course of one year in the quarterly dosing group (mean expected/actual headache days [HD]: 211/134) and an average of 86 HFD (mean expected/actual: 212/126) in the monthly dosing group. For EM patients, the analysis also observed patients in the quarterly dosing group gained an average of 58 HFD (mean expected/actual HD: 112/53) and an average of 54 HFD (mean expected/actual HD: 111/57) in the monthly dosing group.

The analysis observed, over the course of one year of fremanezumab treatment, CM patients may gain an average of 2.5-3 months of MFDs or HFDs, and EM patients may gain an average of 1.5-2 months, reducing overall migraine burden for these evaluated patients.

Poster: Consecutive Migraine-free Days with Fremanezumab Treatment: Results of the Double-blind, Placebo-controlled FOCUS Study
This post hoc analysis of the Phase 3b FOCUS study examined the maximum number of consecutive MFD for patients treated with fremanezumab after inadequate response to 2-4 prior migraine preventive medication classes in the FOCUS trial. For 12 weeks of double-blind treatment in FOCUS, 838 eligible patients were randomized one-to-one-to-one to quarterly fremanezumab, monthly fremanezumab or matched placebo. Change from baseline in monthly average maximum number of consecutive MFD was evaluated.

At baseline, mean numbers of maximum consecutive MFD were comparable across treatment groups (quarterly fremanezumab, 5.1 days [2.84]; monthly fremanezumab, 5.1 days [3.11]; placebo, 4.8 days [3.03]). Increases from BL in consecutive MFD during 12 weeks were significantly higher for fremanezumab (least-squares mean [SE] change from baseline during 12 weeks: quarterly, 8.3 [0.82]; monthly, 9.6 [0.81]) versus placebo (4.0 [0.81]; both P<0.0001).

In migraine patients with inadequate response to 2-4 prior migraine preventive medication classes, patients receiving quarterly or monthly fremanezumab as part of this post hoc analysis had significantly more consecutive MFD versus placebo during 12 weeks of treatment.

Poster: Reductions in Migraine Frequency With Fremanezumab Treatment in Individuals With Chronic and Episodic Migraine
This pooled analysis assessed the shift in migraine frequency category for participants treated with fremanezumab from three Phase 3, double-blind, placebo-controlled trials: HALO CM, HALO EM and FOCUS.

In all three studies, patients with CM or EM were randomized one-to-one-to-one to quarterly fremanezumab, monthly fremanezumab or matched placebo. The percentages of patients with a reversion ≥1 category down during 12 weeks of treatment were evaluated by BL frequency category (high-frequency CM [HFCM; ≥19 monthly migraine days (MMD)]; low-frequency CM [LFCM; 15-18 MMD]; high-frequency EM [HFEM; 10-14 MMD]; moderate-frequency [MFEM; 4-9 MMD]).

In this analysis, it was observed that both quarterly and monthly dosing of fremanezumab resulted in favorable migraine frequency category reversions to a greater extent than placebo.

At baseline, 659 patients had LFEM, 515 had HFEM, 511 had LFCM, and 500 had HFCM. Higher proportions of patients with MFEM receiving quarterly dosing (53%) and monthly dosing (52%) of fremanezumab experienced a reversion one category down to LFEM (<4 MMD) versus placebo (29%). Higher proportions of patients receiving quarterly dosing and monthly dosing of fremanezumab versus placebo experienced a reversion ≥1 category down in the BL HFEM subgroup to MFEM or LFEM (quarterly, 77%; monthly, 75%; placebo, 58%), the BL LFCM subgroup to HFEM, MFEM, or LFEM (quarterly, 73%; monthly, 76%; placebo, 57%), or the BL HFCM subgroup to LFCM, HFEM, MFEM, or LFEM (quarterly, 57%; monthly, 59%; placebo, 44%).

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.

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 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 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, 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 Annual Report on Form 10-K for the year ended December 31, 2020, 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.


References

1 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

 

2 Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84:422–435. doi: 10.1016/S0025-6196(11)60561-2.

 

3 Lipton RB, Liberman JN, Kolodner KB, et al. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003;23:441–450. doi: 10.1046/j.1468-2982.2003.00546.x.

 

4 Steiner TJ, Birbeck GL, Jensen RH, Katsarava Z, Stovner LJ, Martelletti P. Headache disorders are third cause of disability worldwide. J Headache Pain. 2015;16:58. doi:10.1186/s10194-015-0544-2

 

5 Migraine Facts. Migraine Research Foundation. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed August 20, 2021.

 


© Business Wire 2021
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