- AJOVY confirms efficacy in new Phase 3 data significantly
reducing the number of migraine days per month
- All critical efficacy endpoints met significance as set out
apriori through hierarchical testing
- AJOVY confirmed a favorable safety profile
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced results from
a Phase 3 study evaluating the efficacy and safety of AJOVY for the
prevention of migraine in adult Chinese patients.
In the study, AJOVY achieved primary endpoint and all secondary
endpoints, significantly reducing the number of migraine days
experienced per month, demonstrating superior efficacy over
placebo. All key secondary endpoints were also met including
measures for early onset of efficacy during the first month,
responder rate analysis defined as 50% reduction of migraine days
and reduction of acute headache medication use over 3 months after
first use. Study data also show AJOVY was safe and well tolerated
with no emerging safety signals. This data is consistent with the
previous Phase 3 data for AJOVY which was approved for the
preventive treatment of migraine in adults in the U.S. in 2018 and
in the EU in 2019.
In China, an estimated 14.3% of non-elderly adults are living
with migraine.1 From this population, approximately
52.9% will visit hospitals and only 13.8% of them will be diagnosed
with migraine.2
“Migraine and its debilitating symptoms impact people around the
world, and these study results from Chinese migraine patients
reinforce AJOVY as a proven preventive medicine that can safely and
effectively help reduce the burden of migraine,” said Eric Hughes,
MD, PhD, Executive Vice President of Global R&D and Chief
Medical Officer at Teva. "China has the largest migraine population
worldwide,3 and Teva is committed to research on a
global scale that helps address unmet need where it exists and
ensure that the role of treatment innovations like AJOVY are better
understood.”
Migraine attacks cause disabling pain, nausea, vomiting and
sensitivities to light and sound, resulting in serious effects on
the ability to complete daily tasks. The burden of migraine and the
fear of the next one can lead to a significant negative impact on
quality of life, including family, social and professional
relationships. People who experience migraine are more likely to
suffer from anxiety and depression compared to healthy
individuals.4
AJOVY is a humanized monoclonal antibody (mAb) which selectively
binds the calcitonin gene-related peptide (CGRP).
In the Phase 3 double-blind study in China, 365 adult
participants were randomized 1:1:2 to receive AJOVY subcutaneously
225mg once-monthly for three months or a single dose of 675mg
once-quarterly or placebo.
"For the many millions of migraine patients in
China,1 there is a need for preventive treatment options
that may help reduce the number of migraine days they experience
and support the alleviation of the incapacitating symptoms migraine
can cause,” said Shengyuan Yu, MD, PhD, Director and Professor,
Department of Neurology, Chinese PLA General Hospital. "These Phase
3 data indicate that fremanezumab has the potential to
significantly improve life quality of the patients with migraine in
China.”
In the study, AJOVY was safe and well tolerated with no safety
signals observed. The most common treatment-related (≥5%) AEs were
injection site reactions.
Additional findings from this study are planned for presentation
at a medical meeting later this year.
About AJOVY Phase 3 Study in China
This multicenter, randomized, double-blind, placebo-controlled
study is evaluating the efficacy, safety and tolerability of
fremanezumab injection for subcutaneous use as a treatment in
patients (ages 18-70 years) with episodic or chronic migraine vs
placebo. The study enrolled 365 patients who were randomized to
receive a subcutaneous injection of fremanezumab once-monthly or
once-quarterly, or placebo in a 1:1:2 ratio. The primary objective
is to demonstrate the efficacy of fremanezumab administered as
once-monthly and once-quarterly subcutaneous injections to adult
Chinese participants with migraine. The secondary objectives are to
further demonstrate the efficacy of fremanezumab administered as
once-monthly and once-quarterly subcutaneous injections and to
evaluate the safety and tolerability of fremanezumab administered
as once-monthly and once-quarterly subcutaneous injections. The
study consists of a screening visit, a baseline period (4 weeks), a
12-week double-blind treatment period, a 12-week open-label
treatment period when all patients receive 225mg of AJOVY monthly,
and a follow-up period lasting 3 months after the last dose of
treatment. The open label phase of the trial is still ongoing.
About AJOVY▼ (fremanezumab-vfrm) injection
AJOVY is indicated for the preventive treatment of migraine in
adults. 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.
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
adult Chinese 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, 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.
______________________
- Takeshima, T., Wan, Q., Zhang, Y. et al. Prevalence, burden,
and clinical management of migraine in China, Japan, and South
Korea: a comprehensive review of the literature. J Headache Pain
20, 111 (2019). https://doi.org/10.1186/s10194-019-1062-4
- Guidelines for the diagnosis and treatment of migraine in China
(2022 edition) Chinese Journal of Pain Medicine Chinese Journal of
Pain Medicine 2022, 28 (12)
- Wang Y, Huang X, Yue S, Liu J, Li S, Ma H, Hu L, Wu J. Secular
Trends in the Incidence of Migraine in China from 1990 to 2019: A
Joinpoint and Age-Period-Cohort Analysis. J Pain Res. 2022 Jan
14;15:137-146. doi: 10.2147/JPR.S337216. PMID: 35058715; PMCID:
PMC8765540.
- Jaimie D Steinmetz, Katrin Seeher, Nicoline Schiess, Emma
Nichols, Bochen Cao, Chiara Servili, Vanessa Cavallera, Christopher
J L Murray, Kanyin Liane Ong, Valery L Feigin, Theo Vos, and Tarun
Dua on behalf of the GBD network. Global, regional, and national
burden of disorders affecting the nervous system, 1990–2021: a
systematic analysis of the Global Burden of Disease Study 2021.
Lancet Neurol. (in press).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240411323269/en/
IR Contacts
Ran Meir +1 (267) 468-4475
Yael Ashman +972 (3) 914 8262
Sanjeev Sharma +1 (973) 658 2700
Media Contacts
Kelley Dougherty +1 (973) 832-2810
Eden Klein +972 (3) 906 2645
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024