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Teva to present new fremanezumab FOCUS Clinical Study Data for the first time at the 13th European Headache Federation Congress

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that data from the Phase IIIb FOCUS study, which evaluated the
efficacy and safety of fremanezumab for the preventive treatment of
migraine in adult patients who previously experienced inadequate
response to two to four classes of migraine preventive treatments, will
be available at the 13th European Headache Federation (EHF)
Congress. This European Congress for healthcare professionals aims to
improve the lives of patients affected by migraine by presenting new
scientific evidence on migraine prevention, associated comorbidities and
the pathogenesis of migraine. EHF is taking place at the ‘Megaron’
Athens International Conference Centre (MAICC), Athens, Greece on May
30th – June 1st 2019.

The FOCUS study is the largest study to date in patients who
inadequately responded to multiple classes of preventive migraine
treatments. It is the first study of its type to be conducted in chronic
as well as episodic migraine patients.

Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine &
Headache at Teva said: “Patients with inadequate response to multiple
migraine preventive treatment classes have significant unmet need for
the management of their disabling migraine. The FOCUS study results
demonstrate the benefit of fremanezumab in addressing the burden of
disease in this difficult-to-treat patient population. Teva is committed
to meet the needs of migraine patients and their families and we will
explore undertaking Phase IV studies with fremanezumab in order to
increase our understanding of the disease.”

Professor of Neurology and Chair of the Leiden Centre for Translational
Neuroscience at Leiden University Medical Centre, Michel D. Ferrari, MD,
PhD, FANA, FRCP said: “The FOCUS study data convincingly show that
patients with difficult to treat migraine, previously not responding to
up to four migraine preventive treatment classes, might still benefit
significantly from treatment with fremanezumab. I am delighted that this
data will be presented for the first time at the EHF Congress in Athens.”

In the FOCUS study, patients treated with fremanezumab experienced
significant reduction in the monthly average number of migraine days
versus placebo over the 12-week treatment period, for both monthly and
quarterly dosing regimens. In addition, patients treated with
fremanezumab experienced significant improvement compared to placebo on
all secondary endpoints for both quarterly and monthly dosing regimens.
Teva will also host a satellite symposium on Friday during the congress.

Notes to the Editor

The full set of Teva-sponsored data to be presented includes:

Oral presentations:

30th May 2019
12.00pm – 12.15pm
Presenter:
Prof. Messoud Ashina

Efficacy and safety of fremanezumab in patients with migraine and
documented inadequate response to 2-4 classes of migraine preventive
treatments: results of the international, multicentre, randomised,
placebo-controlled FOCUS study.

31st May 2019
14.45pm – 15.00pm
Presenter:
Prof. Richard Lipton

Long-term efficacy of fremanezumab in patients who reverted from a
chronic to an episodic migraine classification.

31st May 2019
15.00pm – 15.15pm
Presenter:
Joshua M. Cohen

Efficacy, clinically meaningful responses, and impact on acute headache
medication use with fremanezumab in patients with migraine and
documented inadequate response to 2-4 classes of migraine preventive
treatments: results of the international, multicentre, randomised,
placebo-controlled FOCUS study.

e-Poster presentations

FOCUS Study:
The FOCUS Study provides data in migraine
patients who responded inadequately to two to four classes of prior
migraine preventive medications.

Titles of the presentations include:

Long-Term Study:
The following presentations will be
presented:

Efficacy

Comorbidity/Disability

Meta analyses

Teva Symposium

Migraine Burden in Europe: What Role Can Innovations Play?

Chair: Professor Dimos D. Mitsikostas, MD, PhD, FEAN

Friday 31st May, 15:45 – 17:00, ‘Megaron’
Athens International Conference Centre (MAICC), Alexandra Trianti Hall

Educational Symposium Program Overview:
Migraine remains a
leading cause of disability in the European Union (EU) and is associated
with a substantial economic and societal burden. However, the recent
introduction of monoclonal antibodies (mAbs) that target calcitonin
gene-related peptide into the treatment armamentarium offers a potential
means to ease the burden of migraine on both patients and the EU
healthcare system. This program will examine the epidemiology of
migraine, along with its social and financial impacts; explain the
scientific advancements behind the clinical utility of mAbs; and discuss
findings from 2 clinical studies of the mAb fremanezumab for migraine
prevention; a long-term study and a study in patients with refractory
episodic and chronic migraine.

The full online programme can be accessed via the congresses official
website: https://www.ehf2019.com/calendar

About FOCUS

The Phase IIIb FOCUS study is a multicenter, randomized, double-blind,
parallel-group, placebo-controlled study that evaluated the efficacy,
safety, and tolerability of quarterly and monthly treatment with
fremanezumab, compared to placebo. Adult patients with chronic migraine
or episodic migraine who have responded inadequately to two to four
classes of prior preventive treatments were enrolled in the study.

Inadequate response is defined as: lack of efficacy after at least three
months of therapy at a stable dose; or the patient cannot tolerate the
drug; or the drug is contraindicated; or the drug is not suitable for
the patient. The classes of medications include: beta-blockers,
anticonvulsants, tricyclics, calcium channel blockers, angiotensin II
receptor antagonists, onabotulinumtoxinA, and valproic acid.

In the study, chronic migraine and episodic migraine patients were
randomized in blinded-fashion 1:1:1 into one of three treatment groups –
a quarterly dosing regimen, a monthly dosing regimen or matching
placebo. An open-label extension of three months (weeks 13-24) followed
the placebo-controlled portion of the study.

About Migraine

Migraine is a disabling neurological disease characterized by severe
head pain, nausea and vomiting.i With more than 1 billion
people affected worldwidei, migraine is the third most
prevalent disease in the world.ii

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 specialty
medicines with a portfolio consisting of over 35,000 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 specialty
and biopharmaceutical products. Learn more at www.tevapharm.com

Teva 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
regarding Fremanezumab (commercialized as AJOVY
®),
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. Important factors that could cause or
contribute to such differences include risks relating to:

 
▼ Adverse events should be reported.
 
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.
 

Reporting forms and information can be found at https://www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App
Store. Adverse events should also be reported to Teva – please
refer to local numbers.

 

i Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed November 2018.
ii Migraine Trust. Facts and
Figures. https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/.
Accessed November 2018.

Contacts

Amsterdam
Fiona Cohen +31 6 2008 2545

United States
Doris Saltkill +1(913)777-3343

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