Findings describe long-term and real-world data
across post-hoc and retrospective analyses
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced new data from clinical and real-world analyses examining
the efficacy of AJOVY® (fremanezumab-vfrm) for the treatment of
migraine, which is being presented at the American Headache Society
(AHS) annual meeting, taking place virtually on June 3-6.
AJOVY data presentations span 11 posters and include a 12-month
extension study from the HALO clinical program, which examines the
long-term response of episodic migraine (EM) and chronic migraine
(CM) patients treated with AJOVY.
“Forty percent of migraine patients could benefit from
preventive therapies, however only about 13 percent of these
patients are currently on preventive treatment. 1,2 It’s important
for patients and the healthcare community to know their treatment
options in managing their disease,” said Denisa Hurtukova, MD, VP,
Head of North America Medical Affairs, Teva. “In order to help
address this unmet need, we’re continuing to explore AJOVY in
clinical and real-world settings. We’re pleased to see the data
presented at AHS is examining subgroups of patients who may
experience fewer migraine days with AJOVY.”
Other presentations include an analysis of the real-world impact
of AJOVY on migraine patients with comorbid depression, anxiety or
hypertension (HTN), and a Phase 3b open label extension study from
the FOCUS clinical program of AJOVY treatment in migraine patients
with inadequate response to multiple prior migraine preventive
medication classes.
“These analyses and extension studies of our landmark HALO and
FOCUS clinical programs, evaluating AJOVY over the course of 15
months and the efficacy in patients who’ve failed prior treatments,
reinforce the potential AJOVY can have for patients living with
migraine,” said Joshua M. Cohen, MD, MPH, FAHS, Global Medical
Therapeutic Area Lead for Migraine & Headache, Teva.
AJOVY is the first and only long-acting anti-CGRP subcutaneous
injection approved in the US for the preventive treatment of
migraine in adults that offers both quarterly and monthly dosing
options.3+±
Clinically Meaningful Responses to Fremanezumab Treatment in
Episodic and Chronic Migraine Over the Course of 15 Months
Patients who completed the Phase 3 HALO EM and CM clinical
trial, along with new patients, entered the HALO long-term study. A
post-hoc analysis examined efficacy of AJOVY for reduction from
baseline in monthly migraine days, duration of this response, and
the proportion of participants with sustained response over the
course of 15 months. Data do not include p-values. Both quarterly
and monthly doses of fremanezumab exhibited clinically meaningful
response in EM and CM, based on the reduction from baseline in MMD,
the duration of this response, and the proportion of participants
with response over up to 15 months.
Episodic Migraine Participants
Chronic Migraine Participants
Dosing
Quarterly
Monthly
Quarterly
Monthly
Mean time to achieve ≥50% response
1.7 months
1.7 months
2.5 months
2.3 months
Mean time to achieve ≥75% response
2.4 months
2.7 months
3.1 months
3.1 months
Avg. duration of time that ≥50% response
was maintained
5.4 months
5.1 months
5.0 months
5.2 months
Avg. duration of time that ≥75% response
was maintained
3.8 months
3.8 months
2.8 months
3.9
Proportion of participants who had
sustained ≥50% response over 12 months of treatment
50%
45%
48%
53%
Proportion of participants who had
sustained ≥75% response over 12 months of treatment
31%
36%
38%
29%
This poster, Lasting Clinically Meaningful Responses to
Fremanezumab Treatment in Episodic and Chronic Migraine Over the
Course of 15 Months, is included in the online program.
Real-World Impact of AJOVY Use on Clinical Outcomes Among
Migraine Patients With Comorbid Depression, Anxiety or
Hypertension
An analysis from the Veradigm Health Insights Database evaluated
the real-world impact of AJOVY in migraine patients with comorbid
depression, anxiety or hypertension (HTN). Patients were included
if they were ≥18 years old, had ≥1 migraine diagnosis during the
study period from January 1, 2014–June 30, 2019, and had a
medication record for AJOVY on or after diagnosis during the
identification period (September 1, 2018–December 31, 2018). The
number of patients with migraine in the depression, anxiety and HTN
subgroups were 172, 180 and 142 respectively. The following
outcomes were recorded:
- Depression subgroup: statistically significant
reductions were observed in the follow-up period in the proportion
of patients with depression (−12.2% [P = 0.003]) and in the number
of antidepressant prescriptions used (−0.2 [P = 0.008]).
- Comorbid anxiety subgroup:statistically significant
reductions were observed in the follow up period in the proportion
of patients with anxiety (−7.8% [P = 0.037]), while a
non-significant decrease was observed in the number of anxiolytic
prescriptions used (−0.1 [P = 0.182]).
- HTN subgroup: Out of 142 patients, 80 of them reported a
mean SBP of 127.32 mmHg and a mean DBP of 78.43 mmHg during the
baseline period. Non-significant reductions in SBP and DBP
were observed during the follow-up period (−0.34 and −0.59,
respectively [P = 0.8374 and 0.5624, respectively]).
This real-world study demonstrates a statistically significant
decrease in anti-depressant prescription use for patients with
comorbid depression and in anxiolytic prescription use for patients
with comorbid anxiety. Among patients with comorbid HTN, no
increases were observed in mean SBP and DBP levels with AJOVY
treatment.
This poster, Real-World Impact of AJOVY Use on Clinical Outcomes
Among Migraine Patients With Comorbid Depression, Anxiety or
Hypertension, is included in the online program.
Fremanezumab Treatment in Chronic and Episodic Migraine
Patients With Inadequate Response to 2-4 Prior Classes of Migraine
Preventive Medications
The efficacy of fremanezumab has been demonstrated in adults
with EM and CM who’ve had inadequate response to 2-4 prior classes
of migraine preventive medications in the 12-week, double-blind,
placebo-controlled period (DBP) of the Phase 3b FOCUS study. All
patients who completed the DBP entered the open label extension
(OLE) and received monthly doses of fremanezumab (225 mg) or 3
quarterly doses (month 1/2/3 at 675 mg). Patients with a sustained
response, based on a reduction from baseline of ≥50% or ≥75% in
monthly migraine days, during the 12-week DBP who maintained that
response throughout the 12-week OLE (from month 4 to 6) were
evaluated. Of the 838 patients randomized, 807 completed the
double-blind period and entered the OLE.
With monthly fremanezumab treatment during the OLE, 60% (71/119)
of patients with a ≥50% sustained response during the DBP and 38%
(10/26) of patients with a ≥75% sustained response during the DBP
maintained that response throughout the 12-week OLE. Among patients
with a ≥50% response at the start of the OLE, 65% (218/335)
maintained that response throughout the OLE, while among patients
with a ≥75% response at the start of the OLE, 42% (66/158)
maintained that response throughout the OLE.
The fremanezumab analyses highlight data on sustained clinically
meaningful responses over 6 months in patients with EM or CM and
inadequate response to multiple prior migraine preventive
medication classes.
This poster, Evidence of Maintained Efficacy for Fremanezumab
Treatment in Chronic and Episodic Migraine Patients With Inadequate
Response to 2-4 Prior Classes of Migraine Preventive Medications,
is included in the online program.
This year’s annual AHS meeting is fully virtual. Data
presentations can be accessed by registering for the meeting.
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.
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
regarding 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:
- the commercial success of AJOVY;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; 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, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the COVID-19 pandemic and its impact on our business,
financial condition, operations, cash flows, and liquidity and on
the economy in general; 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; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; manufacturing or quality control problems; interruptions
in our supply chain; disruptions of information technology systems;
breaches of our data security; variations in intellectual property
laws; challenges associated with conducting business globally,
including political or economic instability, major hostilities or
terrorism; 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; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; significant sales to a limited number
of customers; our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and our prospects and opportunities for
growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities (including as a result of
potential tax reform in the United States); and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release and in our
Quarterly Report on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31,
2020, including in the sections captioned "Risk Factors” and
“Forward Looking Statements.” 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
- Lipton RB, et al. Neurology 2007;68:343–49
- Vander Pluym J, et al. Headache 2016;56:1335–43
- AJOVY® (fremanezumab-vfrm) injection, for subcutaneous use
[prescribing information]. Teva Pharmaceuticals USA, Inc.: North
Wales, PA; 2020.
+ “Long-acting” defined as efficacy measured
over a 12-week period following a 675 mg (225 mg x 3) SC dose.2 ±
225 mg monthly administered as one subcutaneous injection, or 675
mg every three months (quarterly), which is administered as three
subcutaneous injections.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210603005207/en/
IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Yiu (973) 265-3752
Israel Yonatan Beker 972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024