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The fourth interim analysis of the PEARL Real-World Migraine Prevention Study was presented at the 10th European Academy of Neurology (EAN) Congress in Helsinki.
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A new subanalysis of the PEARL data highlights the potential detrimental impact that pausing treatment can have on patient outcomes.1
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Subanalyses investigating the effect of discontinuing and reinitiating treatment on migraine prophylaxis suggest that reinitiating treatment may be associated with an increase in migraine attacks and a decrease in treatment efficacy.1
Tel Aviv, Israel, June 28, 2024–(Business Wire)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced new data from the fourth interim analysis of the PEARL migraine prevention study with AJOVY.® (fremanezumab) may call into question the basis for the suspension of treatment with calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) required or recommended by some reimbursement authorities after 1 year of continuous use.
A subanalysis of real-world data from PEARL investigated the effect of discontinuing and restarting fremanezumab treatment on monthly migraine days (MMD) in adult patients with episodic or chronic migraine.1 It has been shown that pausing treatment with fremanezumab, a CGRP pathway mAb, may increase monthly migraine days (MMD) after treatment cessation and may result in reduced efficacy when treatment is restarted compared to the first treatment cycle, potentially increasing the burden on migraine patients.
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More than 40% of patients experienced a rapid worsening of migraine headaches (≥50% increase in MMD) in the first and second month after discontinuation.
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The proportion of patients who achieved a ≥50% reduction in MMD at months 1 and 3 was 49.0% and 58.9%, respectively, during the first treatment period (before treatment was discontinued), compared with 35.7% and 45.5%, respectively, at month 2 (after treatment was restarted), indicating reduced efficacy.
“The analysis of the PEARL study is important for clinicians treating patients with intermittent and chronic migraine, as it shows that stopping and restarting treatment can hinder progress in symptom management in some patients. To help migraine sufferers in the long term, it is important to adopt a more individualized treatment approach rather than an evidence-based ‘one size fits all’ strategy,” said Dimos Mitsikostas, professor of neurology at Eginition Hospital, School of Medicine, National and Kapodistrian University of Athens, who presented the data.
Although major headache societies provide guidelines and consensus regarding the initiation and intensification of migraine preventive therapy, there is currently no solid evidence to guide discontinuation of treatment. European Headache Federation (EHF) guidelines recommend considering a break after 12–18 months of continuous treatment, but if deemed necessary, treatment should be continued for as long as necessary.2 A review of the literature suggests that prophylaxis with CGRP pathway mAbs should be discontinued when there appears to be no remaining need for migraine prophylaxis, i.e., fewer than four MMDs.3 Different reimbursement terms across Europe also contribute to these inconsistencies, with some countries mandating a one-year treatment break despite limited supporting data.3
“This new subanalysis calls into question the rationale for mandatory treatment interruptions and highlights that for some patients, treatment interruption may reduce the benefit of migraine relief,” said Pinar Kokturk, M.D., vice president and head of European Medical at Teva. “The PEARL study demonstrates the long-term efficacy and safety of fremanezumab in preventing both episodic and chronic migraine in a real-world setting and highlights the benefits of treatment continuity and an individualized, uninterrupted patient management strategy.”
About AJOVY (fremanezumab-vfrm) Injection
AJOVY is indicated for migraine prevention in adults who have migraine headaches on at least 4 days per month. AJOVY is available as a single-dose injection of 225 mg/1.5 mL in a prefilled syringe or, in some countries, a prefilled pen. Two dosing options are available: 225 mg administered subcutaneously once a month (monthly dosing) or 675 mg administered subcutaneously every 3 months (quarterly dosing). AJOVY can be administered at home by a healthcare professional or by the patient or caregiver. No starting dose is required to begin treatment. AJOVY Europe SmPC here.
About Teva
Teva Pharmaceutical Industries, Inc. (NYSE & TASE: TEVA) is a global pharmaceutical leader with a cross-category portfolio that continues its momentum in discovering, delivering and expanding the development of modern medicines by leveraging its generics expertise and driving innovation. For more than 120 years, Teva’s commitment to improving health has been unwavering. Today, the company’s global network of capabilities enables approximately 37,000 employees across 58 markets to push the boundaries of scientific innovation to deliver high-quality medicines that help improve the health of millions of patients every day. Learn more about how Teva is committed to improving health here. TevaFarm
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current beliefs and expectations and are subject to significant known and unknown risks and uncertainties that could cause future results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements can be identified by the use of words such as “should,” “expects,” “anticipates,” “estimates,” “targets,” “may,” “plans,” “guidance,” “intends,” “projects,” “believes” and other words and terms of similar meaning and expression in connection with discussions of future operating or financial performance. Important factors that could cause or contribute to such differences include risks related to our ability to successfully develop and commercialize AJOVY for migraine prevention in adult patients and our ability to compete successfully in the marketplace, including our ability to develop and commercialize additional medicines. our ability to successfully execute our transformation to growth strategy, including expanding our pipeline of innovative and biosimilar medicines, profitably commercializing our innovative and biosimilar portfolios organically or through business development, and maintaining and focusing our generic medicines portfolio, as well as other factors discussed in this press release, our Quarterly Report on Form 10-Q for the first quarter of 2024, and our Annual Report on Form 10-K for the year ended December 31, 2023, including under the section entitled “Risk Factors.” Any forward-looking statement speaks only as of the date on which it is made, and we undertake 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 place undue reliance on these forward-looking statements.
References:
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Mitsikostas, D., et al. Impact of discontinuing and restarting fremanezumab in migraine management: Fourth interim analysis of the PEARL study. Presented at the European Academy of Neurology (EAN). June 29-July 2, 2024, Helsinki. EAN-EPR-196
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Sacco, S. et al. European Headache League guidelines on the use of monoclonal antibodies targeting the calcitonin gene-related peptide pathway for migraine prophylaxis – 2022 update. Journal of Headache and Pain. 2022 23:67
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Al-Hassany, L. et al. “Implications of ceasing migraine prophylaxis” Journal of Headache and Pain 2023 24:9
View source version on businesswire.com: https://www.businesswire.com/news/home/20240627776221/en/
contact address
Eden Klein, Teva Global Corporate Communications: +972 (3) 906 2645
Fiona Cohen, Teva Corporate Communications Europe: +31 6 2008 2545
