Your browser does not support iframes.
Long-term efficacy and safety data for AJOVY
injection for the preventive treatment of migraine are the highlight of
over 20 abstracts, including four platform presentations
Data for AUSTEDO
further our understanding of treatment for tardive dyskinesia
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the Company will present data at the 71st Annual
Meeting of the American Academy of Neurology (AAN) in Philadelphia from
May 4-10, 2019. The diverse selection of data to be presented includes
research across central nervous system (CNS) disorders, including
migraine, tardive dyskinesia (TD), dyskinesia in cerebral palsy (DCP)
and multiple sclerosis (MS). The research spans pediatric to adult
populations and contains long-term data across two therapeutic areas.
“Improving the lives of patients is Teva’s driving force, and the data
being presented at this year’s AAN meeting are a testament to that
commitment,” said Hafrun Fridriksdottir, Executive Vice President,
Global R&D at Teva. “With a wide range of exciting data on AJOVY®
(fremanezumab-vfrm) injection, accompanied by ongoing research on AUSTEDO®
(deutetrabenazine) tablets, we believe the quality and breadth of Teva’s
findings reinforce the Company’s legacy in diseases of the central
nervous system and focus on improving patient treatment.”
Among the data to be presented for AJOVY®, Teva will
highlight new analyses on the long-term efficacy and safety data from
the long-term extension of the Phase III HALO long-term study in chronic
and episodic migraine. Long-term data presentations include analyses on
efficacy and safety, quarterly dosing persistency, reversion from a
chronic to an episodic migraine classification and quality of life
results. Additional Teva data include a platform presentation on
long-term data from an open-label study of AUSTEDO® treatment
in TD and a poster presentation of the design of a Phase III study
investigating deutetrabenazine for the treatment of DCP.
The full set of Teva-sponsored data to be presented includes:
Other Teva data:
AJOVY is indicated for the preventive treatment of migraine in adults.
AJOVY is 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. 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.
Important Safety Information about AJOVY
AJOVY 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 AJOVY®
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the U.S. Food and Drug Administration for the
treatment of tardive dyskinesia in adults and for the treatment of
chorea associated with Huntington’s disease. Safety and effectiveness in
pediatric patients have not been established.
The use of deutetrabenazine for the treatment of dyskinesia in cerebral
palsy is investigational and not currently approved by the U.S. Food and
Drug Administration or any other country’s regulatory agency for this
Important Safety Information about AUSTEDO
can increase the risk of depression
and suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Anyone considering the use of AUSTEDO
must balance the risks of depression and suicidality with the clinical
need for treatment of chorea. AUSTEDO
contraindicated in patients with Huntington’s disease who are suicidal,
or have untreated or inadequately treated depression.
AUSTEDO® is also contraindicated in: patients with hepatic
impairment; patients taking reserpine or within 20 days of discontinuing
reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or
within 14 days of discontinuing MAOI therapy; and patients taking
tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).
AUSTEDO® may cause a worsening in mood, cognition, rigidity,
and functional capacity in patients with Huntington’s disease.
Tetrabenazine (a closely related VMAT2 inhibitor) causes an increase in
the corrected QT (QTc) interval. A clinically relevant QT prolongation
may occur in some patients treated with AUSTEDO® who are
CYP2D6 poor metabolizers or are co-administered a strong CYP2D6
inhibitor or other drugs that are known to prolong QTc. Neuroleptic
Malignant Syndrome has been observed in patients receiving
tetrabenazine. AUSTEDO® may increase the risk of akathisia,
agitation, and restlessness. AUSTEDO® may cause parkinsonism
in patients with Huntington’s disease. Sedation is a common
dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated
patients and greater than placebo) in controlled clinical studies of
patients with tardive dyskinesia were nasopharyngitis and insomnia. The
most common adverse reactions (>8% of AUSTEDO®-treated
patients and greater than placebo) in a controlled clinical study of
patients with chorea associated with Huntington’s disease were
somnolence, diarrhea, dry mouth, and fatigue.
Please click here
for U.S. Full Prescribing Information, including Boxed Warning.
COPAXONE® is indicated for the treatment of patients with
relapsing forms of multiple sclerosis.
Important Safety Information about COPAXONE
COPAXONE® is contraindicated in patients with known
hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per
mL compared to 4% of those on placebo, and approximately 2% of patients
exposed to COPAXONE® 40 mg per mL compared to none on placebo
experienced a constellation of symptoms that may occur immediately
(within seconds to minutes, with the majority of symptoms observed
within 1 hour) after injection and included at least 2 of the following:
flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea,
throat constriction, and urticaria. In general, these symptoms have
their onset several months after the initiation of treatment, although
they may occur earlier, and a given patient may experience 1 or several
episodes of these symptoms. Typically, the symptoms were transient and
self-limited and did not require treatment; however, there have been
reports of patients with similar symptoms who received emergency medical
Transient chest pain was noted in 13% of COPAXONE® 20 mg per
mL patients compared to 6% of placebo patients, and approximately 2% of
COPAXONE® 40 mg per mL patients compared to 1% on placebo.
While some episodes of chest pain occurred in the context of the
immediate post-injection reaction described above, many did not. The
temporal relationship of this chest pain to an injection was not always
known. The pain was usually transient, often unassociated with other
symptoms, and appeared to have no clinical sequelae. Some patients
experienced more than 1 such episode, and episodes usually began at
least 1 month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection site
skin necrosis may occur. Lipoatrophy may occur at various times after
treatment onset (sometimes after several months) and is thought to be
permanent. There is no known therapy for lipoatrophy.
Because COPAXONE® can modify immune response, it may
interfere with immune functions. For example, treatment with COPAXONE®
may interfere with recognition of foreign antigens in a way that would
undermine the body’s tumor surveillance and its defenses against
infection. There is no evidence that COPAXONE® does this, but there has
not been a systematic evaluation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most
common adverse reactions with COPAXONE® vs placebo were
injection site reactions (ISRs), such as erythema (43% vs 10%);
vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and
chest pain (13% vs 6%).
In a controlled study of COPAXONE® 40 mg per mL, the most
common adverse reactions with COPAXONE® vs placebo were ISRs, such as
erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to
discontinuation of COPAXONE®. ISRs, such as erythema, pain,
pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred
at a higher rate with COPAXONE® than placebo.
Please click here
for Full Prescribing Information.
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.
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. 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, 2018, including the sections thereof 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
View source version on businesswire.com:
Kevin C. Mannix, (215)
591-8912Ran Meir, 972 (3) 926-7516
Doris Saltkill, (913)
777-3343IsraelYonatan Beker, 972 (54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.