New AJOVY® (fremanezumab) Migraine Prevention Data Challenges Treatment Pauses

• 4th interim analysis of PEARL real world migraine prevention study presented at 10th European Association of Neurology (EAN) congress in Helsinki

• New sub-analysis of PEARL data highlights potential negative impact of treatment pauses on patient outcomes¹

• Sub-analysis exploring impact of treatment cessation and reinitiation on migraine prevention suggests potential rise in migraine attacks and diminished treatment effectiveness upon reinitiation¹

TEL AVIV, Israel - BUSINESS WIRE: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announces new data from the 4th interim analysis of the PEARL migraine prevention study with AJOVY^® (fremanezumab) that may challenge the rationale for treatment pauses with calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) mandated or recommended by some reimbursement authorities after one year of continuous use.

The sub-analysis from the PEARL real world data explored the impact of fremanezumab treatment cessation and reinitiation on monthly migraine days (MMD) in adult patients with episodic or chronic migraine. The data¹ show that pausing treatment of fremanezumab, a CGRP-pathway mAb, may result in a potential rise in monthly migraine days (MMD) following treatment cessation and reduced effectiveness upon reinitiation compared to the first treatment cycle, adding to the burden of the individual living with migraine:  

• Over 40% of patients experienced a rapid worsening of their migraine (>=50% increase in MMD) at Months 1 and 2 post-cessation.
• The proportion of patients achieving >=50% reduction in MMD at Month 1 and Month 3, respectively, was 49.0% and 58.9% in the first treatment period (before cessation) versus a lower effectiveness of 35.7% and 45.5% in the second treatment period (after treatment reinitiation).

Presenting the data, Dimos Mitsikostas, Professor of Neurology, Aeginition Hospital, Medical School of the National & Kapodistrian University of Athens said “The PEARL Study analysis is significant for clinicians treating people with episodic and chronic migraine as it shows that treatment cessation and reinitiation can disrupt the progress made in managing the condition in some of them. It is important that we are guided by the evidence and adopt a more personalised treatment approach and not a ‘one size fits all’ strategy in helping people with migraine long-term.”

Although leading headache societies provide guidelines and consensus for beginning and escalating migraine prophylactic therapies, robust evidence to guide therapy discontinuation is currently lacking. The European Headache Federation (EHF) guidelines suggest considering a pause after 12-18 months of continuous treatment, but if deemed necessary, treatment should be continued as long as is necessary.²  A review of literature suggests stopping prophylaxis with CGRP-pathway mAbs when there appears to be a  lack of remaining need for migraine prevention, which would be less than four MMDs.³  Differing reimbursement conditions across Europe also contribute to these inconsistencies, with some  countries mandating one-year treatment pauses, despite limited supporting data.³

“This new sub-analysis may challenge the rationale for mandatory treatment pauses and highlights the potential for these breaks to diminish the benefits achieved in reducing migraine for some patients," said Pinar Kokturk, M.D. Vice President & Head of Medical Affairs Europe at Teva. “The PEARL study demonstrates the long-term effectiveness and safety of fremanezumab in preventing both episodic and chronic migraine in a real-world setting and underscores the benefit of treatment continuity and individualised, uninterrupted patient management strategies.”

About AJOVY (fremanezumab-vfrm) injection
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. AJOVY European SmPC can be found here.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com