Idec (NASDAQ: BIIB) and Elan
Corporation, plc (NYSE: ELN) announced that they have submitted
applications to the U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) requesting updates to the TYSABRI®
(natalizumab) labels. The applications request an expanded indication
that would include first-line use for people living with certain
relapsing forms of multiple sclerosis (MS) who have tested negative for
antibodies to the JC virus (JCV). A formal assessment of both
applications is ongoing.
These submissions are supported by risk stratification data and a risk
algorithm that enables physicians and individuals living with MS to make
informed decisions when considering treatment with TYSABRI. If approved,
a first-line label will allow all appropriate anti-JCV antibody negative
patients to consider TYSABRI early in the course of treatment,
regardless of the level of disease activity or prior treatment history.
TYSABRI is a highly efficacious treatment that has been shown to slow
disability progression by 42 – 54 percent and reduce annualized relapse
rates by 68 percent.
"Our anti-JCV antibody test, STRATIFY JCV®, helps to
determine the most appropriate patients for TYSABRI and the data
collected to date supports our recent filing for first-line use,” said
Alfred Sandrock, M.D., Ph.D., senior vice president, Development
Sciences and Chief Medical Officer, Biogen Idec. "Many appropriate
patients are already benefiting from TYSABRI. A first line approval
would allow people with MS access to a highly efficacious treatment
earlier in the course of the disease, potentially leading to better
outcomes. This is an important consideration for people with MS who may
want or need more efficacy.”
Currently in the U.S., due to an increased risk of an opportunistic
viral infection, progressive multifocal leukoencephalopathy (PML),
TYSABRI is generally recommended for people living with relapsing forms
of MS whose disease is not responding to, or who are unable to tolerate,
an alternative therapy regardless of JCV status. In the EU, TYSABRI is
approved for highly active relapsing-remitting MS (RRMS) in adult
patients who have failed to respond to beta interferons or have rapidly
evolving, severe RRMS.
"TYSABRI is an important treatment option for thousands of people living
with MS,” said Hans Peter Hasler, chief operating officer, Elan
Corporation, plc. "We are excited about these filings and the potential
to make TYSABRI available as a treatment option for more individuals
early in the course of their disease.”
TYSABRI is approved in more than 65 countries.
TYSABRI is approved in the United States as a monotherapy for relapsing
forms of MS, generally for patients who have had an inadequate response
to, or are unable to tolerate, an alternative MS therapy. In the
European Union, it is approved for highly active relapsing-remitting MS
(RRMS) in adult patients who have failed to respond to beta interferons
or have rapidly evolving, severe RRMS.
TYSABRI has advanced the treatment of MS with its established efficacy.
Data from the Phase 3 AFFIRM trial, which was published in the New
England Journal of Medicine, showed that after two years, TYSABRI
treatment led to a 68 percent relative reduction (p<0.001) in the
annualized relapse rate when compared with placebo and reduced the
relative risk of disability progression by 42-54 percent (p<0.001).
TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain which usually leads
to death or severe disability. Infection by the JC virus (JCV) is
required for the development of PML and patients who are anti-JCV
antibody positive have a higher risk of developing PML. Factors that
increase the risk of PML are the presence of anti-JCV antibodies, prior
immunosuppressant use, and longer TYSABRI treatment duration. Patients
who have all three risk factors have the highest risk of developing PML.
Other serious adverse events that have occurred in TYSABRI-treated
patients include hypersensitivity reactions (e.g., anaphylaxis) and
infections, including opportunistic and other atypical infections.
Clinically significant liver injury has also been reported in the
post-marketing setting. A list of adverse events can be found in the
full TYSABRI product labeling for each country where it is approved.
TYSABRI is marketed and distributed by Biogen Idec Inc. and Elan
Corporation, plc. For full prescribing information and more information
about TYSABRI, please visit www.biogenidec.com
About Biogen Idec
Biogen Idec uses cutting-edge science to
discover, develop, manufacture and market therapies for serious diseases
with a focus on neurology, immunology and hemophilia. Founded in 1978,
Biogen Idec is the world's oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies
and the company generates more than $4 billion in annual revenues. For
product labeling, press releases and additional information about the
company, please visit www.biogenidec.com.
Elan Corporation, plc is a neuroscience-focused
biotechnology company committed to making a difference in the lives of
patients and their families by dedicating itself to bringing innovations
in science to fill significant unmet medical needs that continue to
exist around the world. Elan shares trade on the New York and Irish
Stock Exchanges. For additional information about Elan, please visit www.elan.com.
This press release includes forward-looking
statements, including statements about regulatory actions and the
development and commercialization of TYSABRI in MS. 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
obtaining regulatory approval, the occurrence of adverse safety events,
product competition, the availability of reimbursement for our products,
adverse market and economic conditions, problems with our manufacturing
processes and our reliance on third parties, failure to comply with
government regulation and possible adverse impact of changes in such
regulation, our ability to protect our intellectual property rights and
the cost of doing so, and the other risks and uncertainties that are
described in the Risk Factors section of our most recent annual or
quarterly report and in other reports we have filed with the SEC. These
statements are based on our current beliefs and expectations and speak
only as of the date of this press release. We do not undertake any
obligation to publicly update any forward-looking statements.