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FOCUS study met all primary and secondary endpoints in both the
quarterly and monthly dosing regimens in patients with chronic and
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced positive topline results from the Phase IIIb FOCUS study that
evaluated the efficacy and safety of fremanezumab for the preventive
treatment of migraine in adult patients who previously experienced
inadequate responses to two to four classes of preventive treatments. In
the study of 838 patients, including those who suffer from either
chronic or episodic migraine, patients treated with fremanezumab
experienced highly significant reduction in the monthly average number
of migraine days versus placebo (-0.6 days) over the 12 week assessment
period, for both monthly (-4.1 days, p<0.0001) and quarterly (-3.7 days,
p<0.0001) 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. There were no safety signals
detected in the study.
“We are pleased to share the topline results of this study,” said Danny
McBryan, M.D., Senior Vice President, Head of Global Medical Affairs and
Pharmacovigilance at Teva. “This study design is distinct in that it is
the largest trial to date in patients who failed to respond to multiple
classes of preventive migraine treatments, and is the first study of its
type to be conducted in chronic, as well as episodic, migraine patients.”
Teva plans to submit the full results for medical meetings in 2019, as
well as peer-reviewed publication.
“With robust effect sizes for the primary endpoint, the FOCUS trial
produced clinically meaningful results that demonstrated the
effectiveness of fremanezumab in a population of patients that are
difficult to treat and who require other treatment options,” said
Matthias Mueller, M.D. MSc, Vice President Global Medical Affairs, Head
of Therapeutic Areas and Scientific Communications at Teva. “We look
forward to bringing forward additional insights from the study in the
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; 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.
Migraine is a disabling neurological disease
characterized by severe head pain, nausea and vomiting.1 With
more than 1 billion people affected worldwidei, migraine is
the third most prevalent illness in the world.2
Fremanezumab is a humanized monoclonal
antibody that binds to the calcitonin gene-related peptide (CGRP) ligand
and blocks its binding to the receptor.
In the U.S., it is marketed as AJOVYTM (fremanezumab-vfrm)
injection, indicated for the preventive treatment of migraine in adults,
and available as a 225 mg/1.5mL single dose injection in a prefilled
syringe with two dosing options – 225 mg monthly administered as one
subcutaneous injection, or 675 mg every three months (quarterly),
administered as three subcutaneous injections. No starting dose is
required to begin treatment.
IMPORTANT SAFETY INFORMATION
is contraindicated in patients with serious hypersensitivity to
fremanezumab-vfrm or to any of the excipients.
Hypersensitivity Reactions: Hypersensitivity reactions, including
rash, pruritus, drug hypersensitivity, and urticaria, were reported with
AJOVY in clinical trials. Most reactions were mild to moderate, but some
led to discontinuation or required corticosteroid treatment. Most
reactions were reported from within hours to one month after
administration. If a hypersensitivity reaction occurs, consider
discontinuing AJOVY and institute appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5% and
greater than placebo) were injection site reactions.
Please click here
for full Prescribing Information for AJOVYTM
Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a global leader in generic medicines, with innovative
treatments in select areas, including CNS, pain and respiratory. We
deliver high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an established
presence in generics, specialty, OTC and API, building on more than a
century-old legacy, with a fully integrated R&D function, strong
operational base and global infrastructure and scale. We strive to act
in a socially and environmentally responsible way. Headquartered
in Israel, with production and research facilities around the globe, we
employ 45,000 professionals, committed to improving the lives of
millions of patients. Learn more at www.tevapharm.com.
Teva Cautionary Note Regarding Forward-Looking Statements
press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 regarding
Fremanezumab (commercialized as AJOVY
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:
and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2017, including in the section captioned “Risk
Factors,” and in our other filings with the U.S. Securities and Exchange
Commission, which are available at
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
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.
View source version on businesswire.com:
IR ContactsKevin C. Mannix(215) 591-8912orRan
Meir972 (3) 926-7516orPR ContactsUnited StatesDoris
Saltkill(913) 777-3343orIsraelYonatan Beker972
(54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.