Study examined efficacy of AJOVY, atogepant and
rimegepant in the prevention of episodic migraine
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced results from a network meta-analysis examining the
efficacy of AJOVY (fremanezumab-vfrm), atogepant and Nurtec® ODT
(rimegepant) in the preventive treatment of episodic migraine (EM).
This data will be presented as a late-breaker ePoster during the
International Headache Society (IHS) and European Headache
Federation (EHF) Joint Congress taking place virtually on Sept.
8-12, 2021.
AJOVY is the first and only long-acting (defined as efficacy
measured over a 12-week period following a 675 mg [225 mg x 3]
subcutaneous dose) anti-CGRP subcutaneous injection approved for
the preventive treatment of migraine in adults with both quarterly
and monthly dosing options.1+±
Migraine is a disabling chronic neurological disease that causes
head pain and associated symptoms so severe that people often
cannot function during an attack. Migraine reduces quality of life
and disrupts the lives of those suffering from migraine and their
ability to perform daily activities.2,1 It is among the top 10
causes of disability worldwide.2
“As migraine is so prevalent affecting one billion people
worldwide3, it’s important for us to explore fremanezumab’s full
treatment potential to ensure we’re offering patients an option to
help prevent their migraine attacks,” said Matthias Mueller, MD
MSc, VP Global Medical Affairs at Teva. “We’re pleased to see the
migraine treatment landscape continue to advance, and these latest
data provide clinicians with new insights into the impact of
choosing a treatment option for each individual patient, reducing
this migraine burden for patients.”
The meta-analysis indirectly assessed changes from baseline in
monthly migraine days (MMD) and 50 percent reduction from baseline
in MMD for patients receiving AJOVY, atogepant and rimegepant
compared to placebo.
Additional retrospective post hoc analyses were conducted to
understand migraine and headache frequency and severity for chronic
migraine (CM) and EM patients who were treated with AJOVY. The
analyses included patients who were initially enrolled in the Phase
3 HALO and FOCUS clinical programs. No determination of statistical
significance can be made, and individual results may vary. No new
safety signals were identified against the known safety profile of
AJOVY.
Late-Breaker ePoster: Network Meta-analysis on Monthly
Migraine Day Reductions with Fremanezumab, Rimegepant, and
Atogepant in the Prevention of Episodic Migraine This
meta-analysis assessed relative efficacy for AJOVY monthly (MLY)
and quarterly (QLY) dosing, atogepant daily (QD) and twice-daily
(BID) dosing, and rimegepant every-other-day (QOD) dosing in the
preventive treatment of EM.
Results observed in this analysis are as follows:
Pairwise Comparisons of the Change from Baseline in MMD at a
12-Week Follow-upa (Mean Difference [95% credible interval])
AJOVY MLY 225 mg
AJOVY QLY 675 mg
Versus…
−1.30 [−2.10, −0.51]
−1.02 [−1.86, −0.17]
Rimegepant 75 mg QOD
−1.00 [−1.65, −0.34]
−0.71 [−1.42, −0.01]
Atogepant 10 mg QD
−0.97 [−1.60, −0.35]
−0.69 [−1.37, −0.00b]
Atogepant 30 mg QD
−0.92 [−1.54, −0.30]
−0.64 [−1.32, 0.05]
Atogepant 60 mg QD
−0.52 [−1.50, 0.45]
−0.24 [−1.25, 0.78]
Atogepant 30 mg BID
−0.62 [−1.44, 0.21]
−0.33 [−1.20, 0.53]
Atogepant 60 mg BID
a1-12 weeks; 9-12 weeks for Rimegepant
bExact value with 3 decimal places: −0.004
The following poster presentations are also available as part of
the virtual joint congress:
Poster: Time Gained with Long-term Fremanezumab Treatment in
Patients with Chronic and Episodic Migraine This post hoc
analysis assessed the number of headache-free days (HFD) and
migraine-free days (MFD) in patients using fremanezumab from a
one-year extension study of the HALO program (HALO LTS). Patients
were randomized one-to-one to receive quarterly or monthly dosing
of fremanezumab.
Migraine-Free Days It was observed that CM patients
gained an average of 80 MFD over the course of one year in the
quarterly dosing group (mean expected/actual migraine days [MD]:
214/134) and an average of 91 MFD (mean expected/actual MD:
214/124) in the monthly dosing group. For EM patients, the analysis
observed patients in the quarterly dosing group gained an average
of 65 MFD (mean expected/actual MD: 120/55) and patients in the
monthly dosing group gained an average of 62 MFD (mean
expected/actual MD: 119/57).
Headache-Free Days It was observed that CM patients
gained an average of 78 HFD over the course of one year in the
quarterly dosing group (mean expected/actual headache days [HD]:
211/134) and an average of 86 HFD (mean expected/actual: 212/126)
in the monthly dosing group. For EM patients, the analysis also
observed patients in the quarterly dosing group gained an average
of 58 HFD (mean expected/actual HD: 112/53) and an average of 54
HFD (mean expected/actual HD: 111/57) in the monthly dosing
group.
The analysis observed, over the course of one year of
fremanezumab treatment, CM patients may gain an average of 2.5-3
months of MFDs or HFDs, and EM patients may gain an average of
1.5-2 months, reducing overall migraine burden for these evaluated
patients.
Poster: Consecutive Migraine-free Days with Fremanezumab
Treatment: Results of the Double-blind, Placebo-controlled FOCUS
Study This post hoc analysis of the Phase 3b FOCUS study
examined the maximum number of consecutive MFD for patients treated
with fremanezumab after inadequate response to 2-4 prior migraine
preventive medication classes in the FOCUS trial. For 12 weeks of
double-blind treatment in FOCUS, 838 eligible patients were
randomized one-to-one-to-one to quarterly fremanezumab, monthly
fremanezumab or matched placebo. Change from baseline in monthly
average maximum number of consecutive MFD was evaluated.
At baseline, mean numbers of maximum consecutive MFD were
comparable across treatment groups (quarterly fremanezumab, 5.1
days [2.84]; monthly fremanezumab, 5.1 days [3.11]; placebo, 4.8
days [3.03]). Increases from BL in consecutive MFD during 12 weeks
were significantly higher for fremanezumab (least-squares mean [SE]
change from baseline during 12 weeks: quarterly, 8.3 [0.82];
monthly, 9.6 [0.81]) versus placebo (4.0 [0.81]; both
P<0.0001).
In migraine patients with inadequate response to 2-4 prior
migraine preventive medication classes, patients receiving
quarterly or monthly fremanezumab as part of this post hoc analysis
had significantly more consecutive MFD versus placebo during 12
weeks of treatment.
Poster: Reductions in Migraine Frequency With Fremanezumab
Treatment in Individuals With Chronic and Episodic Migraine
This pooled analysis assessed the shift in migraine frequency
category for participants treated with fremanezumab from three
Phase 3, double-blind, placebo-controlled trials: HALO CM, HALO EM
and FOCUS.
In all three studies, patients with CM or EM were randomized
one-to-one-to-one to quarterly fremanezumab, monthly fremanezumab
or matched placebo. The percentages of patients with a reversion ≥1
category down during 12 weeks of treatment were evaluated by BL
frequency category (high-frequency CM [HFCM; ≥19 monthly migraine
days (MMD)]; low-frequency CM [LFCM; 15-18 MMD]; high-frequency EM
[HFEM; 10-14 MMD]; moderate-frequency [MFEM; 4-9 MMD]).
In this analysis, it was observed that both quarterly and
monthly dosing of fremanezumab resulted in favorable migraine
frequency category reversions to a greater extent than placebo.
At baseline, 659 patients had LFEM, 515 had HFEM, 511 had LFCM,
and 500 had HFCM. Higher proportions of patients with MFEM
receiving quarterly dosing (53%) and monthly dosing (52%) of
fremanezumab experienced a reversion one category down to LFEM
(<4 MMD) versus placebo (29%). Higher proportions of patients
receiving quarterly dosing and monthly dosing of fremanezumab
versus placebo experienced a reversion ≥1 category down in the BL
HFEM subgroup to MFEM or LFEM (quarterly, 77%; monthly, 75%;
placebo, 58%), the BL LFCM subgroup to HFEM, MFEM, or LFEM
(quarterly, 73%; monthly, 76%; placebo, 57%), or the BL HFCM
subgroup to LFCM, HFEM, MFEM, or LFEM (quarterly, 57%; monthly,
59%; placebo, 44%).
Information for Europe about AJOVY▼ can be found
here.
▼Adverse events should be reported.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
events. Reporting forms and information can be found at
https://www.hpra.ie. Adverse events should also be reported to Teva
– please refer to local numbers.
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. Cases of anaphylaxis and
angioedema have been reported in the postmarketing setting. If a
hypersensitivity reaction occurs, consider discontinuing AJOVY and
institute appropriate therapy.
Adverse Reactions: The most common adverse reactions in
clinical trials (≥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 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,
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 Annual Report on Form 10-K for the year ended
December 31, 2020, 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.
References
1 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
2 Buse DC, Rupnow MF, Lipton RB. Assessing
and managing all aspects of migraine: migraine attacks,
migraine-related functional impairment, common comorbidities, and
quality of life. Mayo Clin Proc. 2009;84:422–435. doi:
10.1016/S0025-6196(11)60561-2.
3 Lipton RB, Liberman JN, Kolodner KB, et
al. Migraine headache disability and health-related
quality-of-life: a population-based case-control study from
England. Cephalalgia. 2003;23:441–450. doi:
10.1046/j.1468-2982.2003.00546.x.
4 Steiner TJ, Birbeck GL, Jensen RH,
Katsarava Z, Stovner LJ, Martelletti P. Headache disorders are
third cause of disability worldwide. J Headache Pain. 2015;16:58.
doi:10.1186/s10194-015-0544-2
5 Migraine Facts. Migraine Research
Foundation.
https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed August 20, 2021.
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