Findings from a retrospective U.S. electronic
medical record study on use of AJOVY and concomitant gepants for
preventive migraine treatment reported in a late-breaking poster
presentation
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced results from
a U.S. retrospective study examining real-world concomitant use of
AJOVY (fremanezumab-vfrm) injection and gepants in the prevention
and acute treatment of migraine. The data showing a reduction in
monthly migraine days with the treatment combination were presented
as a late-breaking poster during the 2022 American Headache Society
(AHS) Annual Meeting held June 9-12, 2022, in Denver, Colorado.
Data presentations at AHS included eight abstracts examining
real-world use of AJOVY across different patient populations and
clinical circumstances. In an additional poster presentation,
results of a subgroup analysis from the Phase 3b FOCUS study
examining the use of AJOVY in patients with difficult-to-treat
migraine and comorbid obesity were reported. The real-world
effectiveness of fremanezumab in patients with refractory migraine
from a US tertiary headache center who switched from erenumab study
was also highlighted.
“The breadth of real-world evidence presented at this year’s AHS
meeting across different patient populations and practice settings
underscores the value of AJOVY in helping to manage this disabling
neurological disease,” said Denisa Hurtukova, MD, VP, Head of North
America Medical Affairs. “As the migraine treatment landscape
continues to advance, these data provide important insights about
AJOVY in real-world settings and its use as a migraine preventive
treatment across a spectrum of patients.”
Real-World Effectiveness and Tolerability of Fremanezumab for
the Preventive Treatment of Migraine in Patients Using Concomitant
Gepants for Acute Treatment in a US Neurology Practice
The US retrospective chart review study examined data from
electronic medical records of 55 adult patients (age 18 and older)
from the Dent Neurologic Institute, a multi-location practice in
New York, who used AJOVY for preventive migraine treatment and
concomitant gepants for acute migraine treatment between January 1,
2020 and May 1, 2021. Data were collected on patients with chronic
and episodic migraine. Patients were on a gepant therapy for one or
more months pre- and post-initiation of AJOVY as add-on therapy.
Patients with three or more measurements of monthly migraine days
(MMD) were included in the analysis: one at the pre-index date
(gepant initiation), one at index (AJOVY initiation), and one at
the post-index period (gepant + AJOVY).
At the time of AJOVY initiation, patients had an average
(standard deviation) of 15.8 (7.4) MMD. The average time from the
index date to the last visit was 9.4 (4.5) months. The average
change in MMD from the index to the post-index date was -6.5 (1.0)
days, representing a 41.1% reduction. Five patients (9.1%) had
adverse events post-index; 3 injection site reactions, 1 uveitis
and 1 upset stomach.
“Millions of people suffer from migraine and its debilitating
effects, and finding the right treatment combination can be
challenging. Different treatment approaches can be used
synergistically, but given that these are relatively new
treatments, real-world data on the concomitant use of AJOVY and
gepants is limited,” said Jennifer McVige, M.D., MA, Attending
Neurologist, DENT Neurologic Institute in Amherst, NY. “This study
provides some of the first evidence that this treatment combination
resulted in reductions in monthly migraine days. Continued
investigation into this treatment approach is warranted.”
About AJOVY (fremanezumanb-vfrm) Injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a
prefilled syringe or autoinjector with two dosing options – 225 mg
administered monthly as one subcutaneous injection, or 675 mg every
three months (quarterly), which is administered as three
subcutaneous injections. AJOVY can be administered in office by a
healthcare professional or at home by a patient or caregiver. No
starting dose is required to begin treatment. AJOVY is now approved
in 45 countries worldwide.
Indications and Usage
AJOVY is a calcitonin gene-related peptide antagonist indicated
for the preventive treatment of migraine in adults.
U.S. Important Safety Information about AJOVY
(fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients
with serious hypersensitivity to fremanezumab-vfrm or to any of the
excipients. Reactions have included anaphylaxis and angioedema.
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 U.S. Prescribing Information for AJOVY
(fremanezumab-vfrm) injection.
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 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 specialty 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 commercial success of
AJOVY; our ability to successfully compete in the marketplace,
including our ability to develop and commercialize
biopharmaceutical products, competition for our specialty products,
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
uncertainty regarding the COVID-19 pandemic and the governmental
and societal responses thereto; our ability to successfully execute
and maintain the activities and efforts related to the measures we
have taken or may take in response to the COVID-19 pandemic and
associated costs therewith; costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject or
delays in governmental processing time due to travel and work
restrictions caused by the COVID-19 pandemic; 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 2022 and in our Annual Report
on Form 10-K for the year ended December 31, 2021, 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.
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IR Contacts United States Ran Meir (267) 468-4072 Yael
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