Teva Announces First Phase 3 Evidence of Efficacy and Safety of an Anti-CGRP Monoclonal Antibody in Children in AJOVY® (fremanezumab) SPACE Trial for Prevention of Episodic Migraine
18 Luglio 2024 - 2:30PM
Business Wire
- SPACE pediatric Phase 3 study met its primary end point for
efficacy with a significantly greater reduction in Monthly Migraine
Days compared to placebo
- Efficacy is consistent with AJOVY (fremanezumab) pivotal Phase
3 and Real-World Evidence studies in adults with no new emergent
safety signals observed
- Full data to be presented at a medical meeting later in
2024
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced today positive topline results from its Phase 3 SPACE
study evaluating the efficacy of AJOVY (fremanezumab) for the
prevention of episodic migraine in children and adolescent patients
aged 6-17 years. The trial met its primary end point with AJOVY
(fremanezumab) achieving a statistically significant superior
efficacy over 12 weeks of treatment compared to placebo. Safety
data was consistent with that observed in adult populations, with
no emergent safety signals. Full data from the SPACE study will be
presented at a medical meeting later this year.
"The study outcome is excellent news in light of the unmet need
for effective preventive therapies for children and adolescents
living with migraine who are greatly impacted by this debilitating
disease,” said Eric A. Hughes, MD, PhD, Executive Vice President,
Global R&D and Chief Medical Officer, at Teva Pharmaceuticals.
"The SPACE data supports our ambitions to bring the proven benefits
of AJOVY to children and adolescent patients who have fewer
treatment options available to them. I am pleased to see that AJOVY
is continuing to demonstrate its efficacy and safety in different
migraine populations, including pediatric patients.”
The SPACE data are the first Phase 3 trial evidence of safety
and efficacy of an anti-CGRP monoclonal antibody for the treatment
of migraine in a pediatric population. The results have particular
significance given the lack of preventive migraine treatments
approved for use in children and adolescent populations. Teva
continues to study the impact of AJOVY (fremanezumab) in pediatric
patients with chronic migraine.
Migraine is common among children, with an overall estimated
prevalence of 7.7%. The prevalence increases from 5% among children
aged 5 to 10 years to approximately 15% among adolescents.1
Migraine can cause significant disability in children and
adolescents, leading to absence from school, impaired educational
performance and missed social activities.1
About SPACE
SPACE is a multicenter, randomized, double-blind,
placebo-controlled, parallel-group study comparing the efficacy,
safety, and tolerability of subcutaneous administration of
fremanezumab versus placebo over a 12 week period for the
preventive treatment of episodic migraine in 235 pediatric patients
aged 6 to 17 years.
About AJOVY®
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.
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
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: our ability to successfully
develop and commercialize AJOVY for the prevention of migraine in
children and adolescent patients; our ability to successfully
compete in the marketplace including our ability to develop and
commercialize additional pharmaceutical products; our ability to
successfully execute our Pivot to Growth strategy, including to
expand our innovative and biosimilar medicines pipeline and
profitably commercialize the innovative medicines and biosimilar
portfolio, whether organically or through business development, and
to sustain and focus our portfolio of generics medicines; and other
factors discussed in this press release, in our quarterly report on
Form 10-Q for the first quarter of 2024, and in our Annual Report
on Form 10-K for the year ended December 31, 2023, including in the
sections 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:
- Pediatric Migraine, An Update. Greene, Kaitlin. et al;
Neurology clinics, Volume 37, Issue 4, 815-833. August 31, 2019.
https://doi.org/10.1016/j.ncl.2019.07.009
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