Data presented at the European Academy of
Neurology Congress 2023
Teva Pharmaceutical Industries Ltd. today announces further
positive data from the pan-European PEARL study investigating the
impact of AJOVY® (fremanezumab) on the prevention of migraine in a
real-world setting,1 due to be completed in 2024.
The data from the 3rd interim analysis2 reveals that almost 60%
of patients achieved a ≥50% reduction in monthly migraine days from
baseline for migraine prevention, with sustained improvement in
disability scores and acute medication use observed over 12 months.
Treatment persistence rates were high, with 82.3% of patients
remaining on treatment by month 12.
Not only was fremanezumab effective in preventing migraine
attacks in patients with chronic and episodic migraine, but it has
also shown to be effective in reducing the severity and duration of
remaining migraine attacks.
Four abstracts from the third interim analysis of the PEARL
study will be presented at the 9th European Academy of Neurology
(EAN) Congress in Budapest, Hungary. The primary analysis is being
presented as an oral presentation by Professor Cristina Tassorelli,
Department of Brain and Behavioural Sciences, University of Pavia,
Pavia, Italy on July 1, 2023.
Commenting on the findings, Professor Tassorelli said:
“Preventive treatments are of the utmost importance for reducing
the burden of severe migraine, but levels of use of preventive
drugs across Europe are still low, resulting in sub-optimal patient
care. These interim findings add to our growing evidence with
fremanezumab in the real-world, showing how the burden of migraines
can be reduced when an eligible patient has access to monoclonal
antibodies like fremanezumab.”
Pinar Kokturk, M.D. Vice President & Head of Medical Affairs
Europe at Teva, said: “The 3rd interim analysis of the PEARL study
provides valuable insights for clinicians and patients into the
effectiveness of fremanezumab (AJOVY®) in a real-world setting.
Real-world data allows us to bridge the gap between scientific
evidence and the complexities of real-life scenarios, offering a
comprehensive understanding of how treatments truly impact
patients' lives. The PEARL study is particularly relevant to
clinicians due to its large patient cohort, coming from 11
countries across Europe”.1
Editors’ Notes - Summary of PEARL 3rd interim analysis data
set:
PEARL Primary Analysis
Real-world effectiveness & safety of fremanezumab in
migraine: 3rd interim analysis of the pan-European PEARL
study2
PEARL (Pan-European Real World study), a two-year prospective,
observational Phase IV study is investigating the effectiveness of
AJOVY® (fremanezumab) in 1140 patients with chronic or episodic
migraine. Fremanezumab is a humanised monoclonal antibody (mAb)
that selectively targets the calcitonin gene-related peptide (CGRP)
pathway. 968 patients (87.3% female) out of the 1140 study patients
had available data to include in the 3rd interim analysis. The
findings show that 58.5% of the patients had their monthly migraine
days reduced by 50% or more at 12 months of treatment.
Additionally, sustained reduction in disability scores and acute
medication use were observed over 12 months. This interim analysis
included a larger patient population over a longer duration than
previous interim analyses, creating more robust data supporting the
clinical use of fremanezumab.
PEARL Sub-Analyses
Fremanezumab adherence & persistence along with past
& concomitant migraine medication use: PEARL 3rd interim
analysis3
This sub-analysis examined treatment adherence and persistence,
and patient use of acute migraine medications during the study.
High treatment persistence rates were seen in patients taking
fremanezumab with 82.3% remaining on treatment at Month 12. An
alternative calculation method was developed to assess adherence to
fremanezumab, and the results indicated that adherence rates
remained at ≥90% from injection 1–12 months inclusive. The mean
number of days each month that patients used triptans (one of the
most frequently prescribed medications for treating moderate to
severe attacks) decreased to 7.7 days to 2.8 days over 12
months.
Impact of fremanezumab initiation on migraine severity, and
the duration of remaining attacks: 3rd interim analysis of the
PEARL study4
The clinical success of migraine preventive treatment is
typically measured by a reduction in monthly migraine days (MMD)
however, for some patients, the severity and duration rather than
the frequency of migraine attacks has a greater impact on their
daily lives. Increased duration and severity of migraine has been
shown to be associated with increased migraine related disability,
psychological comorbidity and decreased quality of life. This
sub-analysis looked at the impact of fremanezumab on the severity
and duration of remaining migraine attacks. The mean monthly
duration of remaining migraine attacks and monthly mean score for
peak headache severity of remaining migraine attacks decreased at
12 months after fremanezumab initiation. These data suggest that
treatment with fremanezumab can reduce both the duration and
severity of remaining migraine attacks, and can consequently lead
to improvements in quality of life outcomes.
Real-world effectiveness of switching to fremanezumab from
other CGRP pathway targeting mAbs: 3rd interim analysis of the
PEARL study5
In 2022, updates to the European Headache Federation (EHF)
guidelines for the use of CGRP pathway mAbs in migraine prevention
noted that switching from one CGRP pathway mAb to another may be
beneficial for patients experiencing adverse events or a lack of
efficacy.6 In this sub-analysis of PEARL, the effectiveness of
fremanezumab in patients who had previously received another
medication from the CGRP pathway mAb class was assessed. During the
first 6 months of fremanezumab treatment, 32.3% of ‘switch’
patients achieved ≥50% reduction in MMD from baseline. A reduction
of ≥30% in MMD is often considered clinically meaningful in CM
patients7,8 and was observed in 60.9% of switch patients with CM
included in this analysis. These results are consistent with those
observed with fremanezumab in the FINESSE study,9 and suggest that
switching to fremanezumab may offer a beneficial treatment option
in patients for whom other CGRP pathway mAbs have failed due to
inadequate response or tolerability reasons.
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 health care professional
or at home by a patient or caregiver. No starting dose is required
to begin treatment.
Information for Europe about AJOVY can be found
here.
▼ 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. Information can be found at https://www.hpra.ie.
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
innovative 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 innovative 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 development and
commercial success of AJOVY; our ability to successfully compete in
the marketplace, including our ability to develop and commercialize
competition for our innovative medicines, 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, the impact of global
economic conditions and other macroeconomic developments and the
governmental and societal responses thereto, and costs and delays
resulting from the extensive pharmaceutical regulation to which we
are subject; 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 2023 and in our Annual Report on Form 10-K for the year
ended December 31, 2022, 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.
_______________________
1 Ashina, M. et al, PEARL study protocol.
Pain management, 11(6), 647–654. (v0.1) - The two year Pan-
European Real World (PEARL) prospective, observational study of
AJOVY® (fremanezumab).
2 Ashina, M., et al. Real-world
effectiveness & safety of fremanezumab in migraine: 3rd interim
analysis of the pan-European PEARL study. Presented at European
Academy of Neurology (EAN); 1-4 July 2023; Budapest
EAN-EPR-045
3 Tassorelli, C., et al. Fremanezumab
Adherence and Persistence Along with Past and Concomitant Migraine
Medication Use: PEARL 3rd Interim Analysis. Presented at European
Academy of Neurology (EAN); 1-4 July 2023; Budapest EAN-EPO-582
4 Tassorelli, C., et al. Impact of
Fremanezumab Initiation on Migraine Severity and Duration of
Remaining Attacks: 3rd Interim Analysis of the PEARL Study.
Presented at European Academy of Neurology (EAN); 1-4 July 2023;
Budapest EAN-EPO-583
5 Ashina, M., et al. Real-World
Effectiveness of Fremanezumab with Switching from Other CGRP
Pathway Targeting mAbs: PEARL Study 3rd Interim Analysis. Presented
at European Academy of Neurology (EAN); 1-4 July 2023; Budapest
EAN-EPO-075
6 Sacco S., et al. European Headache
Federation guideline on the use of monoclonal antibodies targeting
the calcitonin gene related peptide pathway for migraine prevention
- 2022 update. J Headache Pain. 2022 Jun 11;23(1):67.
7 Dodick DW., et al. Assessing clinically
meaningful treatment effects in controlled trials: chronic migraine
as an example. J Pain. 2015 Feb;16(2):164-75.
8 Tassorelli C., et al. International
Headache Society Clinical Trials Standing Committee. Guidelines of
the International Headache Society for controlled trials of
preventive treatment of chronic migraine in adults. Cephalalgia.
2018 Apr;38(5):815-832.
9 Lee MJ., et al. New migraine
prophylactic drugs: Current evidence and practical suggestions for
non-responders to prior therapy. Cephalalgia. 2023 Feb;43(2).
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