Approval Supported by Largest and Longest Head-to-Head Phase 3 Study
Conducted in Multiple Sclerosis (MS)
ZINBRYTA Significantly Reduced Multiple Measures of Disease Activity
inPatients with Relapsing MS
Company Website:
http://www.biogen.com
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill. -- (Business Wire)
The U.S. Food and Drug Administration (FDA) approved ZINBRYTATM
(daclizumab), a new once-monthly, self-administered, subcutaneous
treatment for relapsing forms of multiple sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie
(NYSE: ABBV) announced today. Because of its safety profile, the use of
ZINBRYTA should generally be reserved for patients who have had an
inadequate response to two or more therapies indicated for the treatment
of multiple sclerosis (MS).
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“The FDA approval of ZINBRYTA reflects our long-term commitment to
bringing therapies to the community that meet the diverse needs of
people living with MS,” said Alfred Sandrock, M.D., Ph.D., executive
vice president and chief medical officer at Biogen. “ZINBRYTA is the
first once-monthly, self-administered treatment in MS, and it
demonstrated superior efficacy over a widely used interferon. Clinical
data showed ZINBRYTA significantly reduced relapses and brain lesions
for up to three years compared to AVONEX® (interferon
beta-1a) intramuscular injection, and has a positive benefit-risk
profile with monthly patient monitoring.”
The FDA approval of ZINBRYTA is primarily based on results from two
clinical trials, including DECIDE, the largest and longest head-to-head
Phase 3 clinical trial ever conducted in MS. The Phase 2b SELECT and
Phase 3 DECIDE studies were global, randomized, double-blind, controlled
studies that involved approximately 2,400 people living with RMS. Some
patients in DECIDE were treated for up to three years.
In DECIDE and SELECT, ZINBRYTA significantly reduced the annualized
relapse rate (ARR), the primary endpoint of the studies, by 45 percent
compared to AVONEX up to 144 weeks and by 54 percent compared to placebo
at 52 weeks (both p<0.0001), respectively.
“MS patients are in need of therapeutic choices to help manage their
disease and ZINBRYTA is an important new option for patients,” said
Michael Severino, M.D., executive vice president, research and
development and chief scientific officer, AbbVie. “AbbVie is committed
to making a remarkable impact on the lives of patients, including in MS
where there are particular unmet needs.”
Results from DECIDE showed that ZINBRYTA demonstrated superior efficacy
across multiple measures of MS disease activity (relapses and MRI)
compared to AVONEX, including a significant reduction in the mean number
of new or newly enlarging T2-hyperintense lesions by 54 percent compared
to AVONEX at 96 weeks (p<0.0001).
Additionally, the study showed at up to 144 weeks on ZINBRYTA, 67
percent of patients were relapse free compared to 51 percent of the
patients taking AVONEX.
The ZINBRYTA label includes a boxed warning for the risk of hepatic
injury, including autoimmune hepatitis, and other immune-mediated
disorders. Because of these risks, access to ZINBRYTA in the United
States is restricted to prescribers, pharmacies and patients enrolled in
the ZINBRYTA Risk Evaluation and Mitigation Strategy (REMS) Program,
which includes required monthly liver function tests.
“MS affects each person differently, so it is critical that people have
additional therapeutic options to address their needs throughout the
course of the disease,” said Jeffrey English, M.D., director of clinical
research, Multiple Sclerosis Center of Atlanta. “ZINBRYTA provides a
meaningful new treatment option that demonstrates efficacy and offers
once-monthly dosing.”
While the precise mechanism of action of ZINBRYTA is unknown, it is
thought to work differently from other disease-modifying therapies by
binding to CD25, a subunit of the interleukin-2 (IL-2) receptor found on
activated lymphocytes, cells believed to underlie the biology of MS.
Total lymphocyte, T and B cell counts decreased less than 10 percent
from baseline during the first year of treatment. The effects on total
lymphocyte counts returned to baseline within approximately eight to 12
weeks after the last dose of ZINBRYTA.
The most common adverse reactions (incidence at least 5 percent and at
least 2 percent higher incidence than comparator) that occurred in
ZINBRYTA-treated patients were nasopharyngitis (inflammation of the nose
and a part of the throat), upper respiratory tract infection, rash,
influenza, dermatitis, oropharyngeal (part of the throat) pain,
bronchitis, eczema, and lymphadenopathy (enlargement of the lymph nodes)
compared with AVONEX; and upper respiratory tract infection, depression,
rash, pharyngitis (inflammation of part of the throat), and increased
alanine aminotransferase (ALT; a type of liver enzyme) compared with
placebo. The U.S. ZINBRYTA prescribing information also includes
warnings and precautions for hepatic injury, immune-mediated disorders,
acute hypersensitivity (inflammatory reaction), infections, depression
and suicide.
For more information on ZINBRYTA, and prescribing
information including the boxed warning, visit www.ZINBRYTA.com.
About the DECIDE Study
DECIDE was a two- to three-year, Phase 3, global, randomized,
double-blind, multicenter study in patients with relapsing forms of
multiple sclerosis (RMS) designed to determine if ZINBRYTA would provide
superior outcomes for certain clinical endpoints compared to treatment
with AVONEX® (interferon beta-1a) 30 mcg intramuscular (IM)
injection. DECIDE was an active comparator study with two groups: 150 mg
of subcutaneous (SC) ZINBRYTA every four weeks (n=919) was compared to
AVONEX IM once weekly (n=922).
About the SELECT Study
SELECT was a multicenter, randomized, double-blind, Phase 2b study that
evaluated the efficacy and safety of ZINBRYTA 150 mg (n=208) and 300 mg
(n=209) subcutaneous every four weeks for one year versus placebo
(n=204) in patients with RMS.
About ZINBRYTA™ (daclizumab)
ZINBRYTA is being developed globally for relapsing forms of multiple
sclerosis (RMS). In the U.S. only, due to its safety profile, ZINBRYTA
is indicated for the treatment of adults with RMS, and should generally
be reserved for patients who have had an inadequate response to two or
more therapies.
The recommended dosage of ZINBRYTA is 150 mg, self-administered
subcutaneously on a monthly basis. The European Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA)
recently granted a positive opinion for ZINBRYTA. The opinion of the
CHMP has been referred to the European Commission for final decision on
approval. ZINBRYTA is also currently under regulatory review in
Switzerland, Canada and Australia.
In clinical trials, ZINBRYTA demonstrated superior efficacy in relapse
reduction and MRI, key measures of MS disease activity, compared to
AVONEX® (interferon beta-1a) IM injection and placebo.
ZINBRYTA is a humanized IgG1 monoclonal antibody that selectively binds
to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25). CD25
is expressed at high levels on T-cells that become activated in people
with MS.
The U.S. ZINBRYTA prescribing information includes a boxed warning for a
risk of hepatic injury and immune-mediated disorders. It also includes
warnings and precautions for hepatic injury, immune-mediated disorders,
acute hypersensitivity, infections, depression and suicide. The most
common adverse reactions (incidence at least 5 percent and at least 2
percent higher incidence than comparator) that occurred in
ZINBRYTA-treated patients were nasopharyngitis, upper respiratory tract
infection, rash, influenza, dermatitis, oropharyngeal pain, bronchitis,
eczema, and lymphadenopathy compared with AVONEX; and upper respiratory
tract infection, depression, rash, pharyngitis, and increased alanine
aminotransferase (ALT) compared with placebo.
Biogen and AbbVie are co-promoting ZINBRYTA in the United States.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, often disabling disease that
attacks the central nervous system, which is made up of the brain,
spinal cord and optic nerves. Symptoms may be mild or severe, ranging
from numbness in the limbs to paralysis or loss of vision. The
progression, severity and specific symptoms of MS are unpredictable and
vary from one person to another.1 MS affects more than 2.3
million people worldwide.2 Relapsing MS is the most common
form of the disease, accounting for 85 percent of cases, and is
characterized by clearly defined acute attacks with full recovery or
with residual deficit upon recovery.3
Patient Support
As part of the companies’ ongoing commitment to people living with MS,
extra support will be provided through Biogen’s Above MS™ program. These
world-class services are thoughtfully crafted around the informational,
emotional, financial and logistical needs that come with living with MS.
Join the Above MS program by calling: 1-800-456-2255, Monday-Friday,
8:30 a.m. - 8 p.m. ET.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release includes forward-looking statements, including
statements about the potential therapeutic effects and benefits of
ZINBRYTA. These forward-looking statements may be accompanied by such
words as "anticipate," "believe," "estimate," "expect," "forecast,"
"intend," "may," "plan," "will," and other words and terms of similar
meaning. You should not place undue reliance on these statements. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such statements,
including uncertainty of success in commercialization of ZINBRYTA, which
may be impacted by, among other things, slower than anticipated
acceptance of ZINBRYTA by patients and the medical community,
competition in the MS market, the effectiveness of sales and marketing
efforts, problems with the manufacturing process for ZINBRYTA, the
occurrence of adverse safety events, difficulties in obtaining or
changes in the availability of reimbursement for ZINBRYTA and Biogen’s
other MS products, failure to obtain regulatory approvals in other
jurisdictions, failure to protect intellectual property and other
proprietary rights, product liability claims, third party collaboration
risks, and the other risks and uncertainties that are described in the
Risk Factors section of Biogen’s most recent annual or quarterly report
and in other reports Biogen has filed with the U.S. Securities and
Exchange Commission (SEC). Any forward-looking statements speak only as
of the date of this press release and Biogen assumes no obligation to
update any forward-looking statements, whether as a result of new
information, future events, or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie
on Twitter or view careers on our Facebook or
LinkedIn
page.
AbbVie Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words "believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations is
set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.
1 National Multiple Sclerosis Society (NMSS). What is MS? Date
accessed: May 27, 2016. http://www.nationalmssociety.org/What-is-MS.
2 NMSS. Who Gets MS? (Epidemiology). Date accessed:
May 27, 2016. http://www.nationalmssociety.org/What-is-MS/Who-Gets-MS.
3 NMSS. Types of MS. Date accessed: May 27, 2016.http://www.nationalmssociety.org/What-is-MS/Types-of-MS.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160527005900/en/
Contacts:
MEDIA CONTACT:
Biogen
Ligia Del Bianco, +1-781-464-3260
public.affairs@biogen.com
or
AbbVie
Jillian
Griffin, +1-847-935-9331
jillian.griffin@abbvie.com
or
INVESTOR
CONTACT:
Biogen
Mike Hencke, +1-781-464-2442
IR@biogen.com
or
AbbVie
Liz
Shea, +1-847-935-2211
elizabeth.shea@abbvie.com
Source: Biogen
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