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Teva to Present New Long-Term Data on Efficacy and Safety of Fremanezumab at 2019 American Academy of Neurology Annual Meeting

Findings describe the efficacy and safety results of clinical trials
of fremanezumab through 12 months of treatment in patients with chronic
and episodic migraine

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced results from new long-term analyses of the efficacy and safety
of fremanezumab, being presented at the 71st Annual Meeting
of the American Academy of Neurology (AAN) in Philadelphia from May
4-10, 2019.

The findings, presented across 13 abstracts at this year’s meeting,
describe the primary and other key endpoints, as well as pooled and
subgroup data from a 52-week, multicenter, randomized, double-blind,
parallel group long-term extension study that evaluated fremanezumab in
adults with migraine. The results presented include data on the efficacy
of fremanezumab observed through 12 months of treatment in patients with
migraine, including populations with inadequate responses to multiple
classes of preventive medications, quality of life and the safety
profile.

“We are pleased to join the neurology community at this year’s AAN
meeting and share these long-term data results on fremanezumab as a
preventive treatment option for patients living with migraine,” said
Danny McBryan, Senior Vice President, Head of Global Medical Affairs and
Pharmacovigilance at Teva. “These data, studied in a wide range of
migraine patient populations, add to our growing body of evidence about
fremanezumab, and further demonstrate our ongoing commitment to
improving the lives of those who suffer from migraine.”

Analysis design

The long-term extension study of fremanezumab included patients rolled
over from two placebo-controlled studies, as well as 312 newly enrolled
patients. Patients were assigned to either monthly dosing (225 mg
monthly; chronic migraine: starting dose of 675 mg), or quarterly dosing
(675 mg every three months). A total of 1,890 patients were enrolled and
1,494 completed 12 months of treatment. Patients included those with
chronic migraine (CM) and episodic migraine (EM).

Analysis highlights

A selection of key data points of note across the analyses are
summarized below.

Long-term efficacy and safety results:

Quarterly dosing persistency results:

Quality of life results:

About fremanezumab

AJOVY® (fremanezumab-vfrm) injection is indicated for the
preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Contraindications: 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®
(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 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
statements.

References:
1Mcallister P,
et al. Long-Term Impact of Fremanezumab on Response Rates, Acute
Headache Medication Use, and Disability in Patients With Chronic
Migraine: Results of a 1-Year Study. Presented at: 2019 AAN Annual
Meeting, Philadelphia, PA.
2Brandes JL, et al. Long-Term
Impact of Fremanezumab on Response Rates, Acute Headache Medication Use,
and Disability in Patients With Episodic Migraine: Results of a 1-Year
Study. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
3Lipton
R, et al. Long-Term Efficacy of Fremanezumab in Patients Who Reverted
From a Chronic to an Episodic Migraine Classification. Presented at:
2019 AAN Annual Meeting, Philadelphia, PA.
4Ning X, et
al. Long-Term Safety of Fremanezumab: Results of a 1-Year Study.
Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
5Blaise
CA, et al. Quarterly Administration of Fremanezumab Does Not Show
“Wearing Off” Effect During Third Month After Injection. Presented at:
2019 AAN Annual Meeting, Philadelphia, PA.
6Cohen J, et
al. Long-Term Impact of Fremanezumab on Headache-Related Disability,
Quality of Life, and Patient Satisfaction in Episodic Migraine and
Chronic Migraine Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.

Contacts

IR Contacts
United States
Kevin C. Mannix, (215)
591-8912
Ran Meir, 972 (3) 926-7516

PR Contacts
United States
Doris Saltkill, (913)
777-3343
Israel
Yonatan Beker, 972 (54) 888 5898

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