|[August 15, 2014]
Biogen Idec's PLEGRIDY™(Peginterferon Beta-1a) Approved in the US for the Treatment of Multiple Sclerosis
CAMBRIDGE, Mass. --(Business Wire)--
Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug
Administration (FDA) has approved PLEGRIDYTM (peginterferon
beta-1a), a new treatment for people with relapsing forms of multiple
sclerosis (RMS). PLEGRIDY,
the only pegylated beta interferon approved for use in RMS, is dosed
once every two weeks and can be administered subcutaneously with the
PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe.
Image of the PLEGRIDY(TM)(peginterferon beta-1a) PEN, a ready-to-use autoinjector for subcutaneous administration. (Photo: Business Wire)
"PLEGRIDY offers people with MS robust efficacy, a safety profile
consistent with the established interferon class, and significantly
fewer injections than other beta interferon treatments," said George A.
Scangos, Ph.D., chief executive officer of Biogen Idec. "PLEGRIDY
represents the most significant innovation in the interferon class in
over a decade, and is the result of our deep commitment to improving the
lives of people with MS and those who care for them."
The FDA approval of PLEGRIDY is based on results from one of the largest
pivotal studies of beta interferon conducted, ADVANCE, which involved
more than 1,500 MS patients. ADVANCE was a two-year, Phase 3,
placebo-controlled (in year one) study that evaluated the efficacy and
safety of PLEGRIDY administered subcutaneously. The analysis for all
primary and secondary efficacy endpoints occurred at the end of year
one. After the first year, patients on placebo received PLEGRIDY for the
duration of the study.
In the first year of the ADVANCE clinical trial, PLEGRIDY dosed once
every two weeks significantly reduced annualized relapse rate (ARR) at
one year by 36 percent compared to placebo (p=0.0007). PLEGRIDY reduced
the risk of 12-week confirmed disability progression, as measured by the
Expanded Disability Status Scale, by 38 percent (p=0.0383) compared to
placebo. PLEGRIDY also significantly reduced the number of new
gadolinium-enhancing [Gd+] lesions by 86 percent (p<0.0001) and reduced
new or newly enlarging T2-hyperintense lesions by 67 percent (p<0.0001)
compared to placebo.
The most common adverse reactions were injection site reaction, flu-like
illness, fever, headache, muscle pain, chills, injection site pain,
weakness, injection site itching and joint pain. The ADVANCE two-year
safety data were consistent with safety results observed in year one.
"PLEGRIDY is a compelling new treatment option for people living with MS
that offers a proven safety profile, strong efficacy and an every two
week dosing schedule administered by an innovative delivery system,"
said Peter Wade, M.D., medical director for neurology at the Mandell
Center for Comprehensive Multiple Sclerosis Care and Neuroscience
Research in Hartford, CT. "As a treating neurologist, I believe these
attributes will appeal to MS patients who look for less frequent dosing
with proven effectiveness."
PLEGRIDY has been recently approved by the European Commission.
"It is always encouraging to have additional treatment options that may
help people with MS manage their disease as we move towards our ultimate
goal of ending MS forever," said Dr. Timothy Coetzee, chief advocacy,
services and research officer at the National MS Society.
For more information on PLEGRIDY, prescribing information and financial
assistance programs visit PLEGRIDY.com
PLEGRIDY is a new subcutaneous injectable therapy indicated for
relapsing forms of MS, in which interferon beta-1a is pegylated to
extend its half-life to permit a less frequent dosing schedule. PLEGRIDY
is a member of the interferon class of treatments for MS.
Clinical and MRI data from the ADVANCE study of PLEGRIDY demonstrated a
reduction in relapses, disability progression and the number of MS
lesions when compared to placebo, and further support its clinical
efficacy profile. The safety and tolerability profile of PLEGRIDY
observed in ADVANCE was consistent with that of established
MS interferon therapies.
The recommended dosage of PLEGRIDY is 125 micrograms injected
subcutaneously every 14 days. Patients should start treatment with 63
micrograms on day one. On day 15, the dose is increased to 94
micrograms, reaching the full dose of 125 micrograms on day 29.
Severe hepatic injury, including hepatitis, autoimmune hepatitis, and
rare cases of severe hepatic failure have been reported with interferon
beta. Elevations in hepatic enzymes and hepatic injury have been
observed with the use of PLEGRIDY in clinical studies. Depression,
suicidal ideation and suicide have been reported in patients receiving
interferon beta. Seizures are also associated with the use of interferon
beta. Anaphylaxis and other serious allergic reactions are rare
complications of treatment with interferon beta. Injection site
reactions, including injection site necrosis, can occur with the use of
subcutaneous interferon beta.
Congestive heart failure, cardiomyopathy and cardiomyopathy with
congestive heart failure occur in patients receiving interferon
beta. Interferon beta can cause decreased peripheral blood counts in all
cell lines, including rare instances of pancytopenia and severe
thrombocytopenia. Autoimmune disorders of multiple target organs
including idiopathic thrombocytopenia, hyper and hypothyroidism, and
autoimmune hepatitis have been reported with interferon beta.
For complete PLEGRIDY prescribing information, please visit PLEGRIDY.com.
Pegylation prolongs the circulation time of the molecule in the body by
increasing its size, thus enabling a longer half-life, stabilizing the
molecule by improving its solubility and shielding the molecule from
enzymes in the body that try to break it down into smaller particles.1
Pegylation is a well-established scientific process that has been
used in other therapeutic categories.
Biogen Idec Patient Support
As part of its ongoing commitment to the MS community, Biogen Idec
provides a variety of support services for patients and caregivers
through MS ActiveSource®. These world-class services
are thoughtfully crafted around the informational, emotional, financial
and logistical needs that come with living with MS.
MS ActiveSource is available via phone (Monday-Friday 8:30 a.m. -
8:00 p.m. ET) at 1-800-456-2255 or via web at MSActiveSource.com.
What is 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. 2 MS affects more than 2.3
million people worldwide.3 Best current estimates indicate
that there are at least 400,000 people with MS in the United States.4
Relapsing forms of MS include: relapsing-remitting MS (RRMS), the most
common form of the disease, which is characterized by clearly defined
acute attacks with full recovery or with residual deficit upon recovery
and progressive-relapsing MS which is characterized by steadily
worsening disease from the beginning with occasional acute attacks like
those experienced by people with RRMS.5
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers,
develops and delivers to patients worldwide innovative therapies for the
treatment of neurodegenerative diseases, hematologic conditions and
autoimmune disorders. Founded in 1978, Biogen Idec is the world's oldest
independent biotechnology company and patients worldwide benefit from
its leading multiple sclerosis and innovative hemophilia therapies. For
product labeling, press releases and additional information about the
Company, please visit http://www.biogenidec.com.
This press release contains forward-looking statements, including
statements about the benefits and impact of PLEGRIDY. These
forward-looking statements may be accompanied by such words as
"anticipate," "believe," "could," "estimate," "expect," "forecast,"
"intend," "may," "plan," "potential," "project," "target," "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 PLEGRIDY, intense competition in the MS market,
unexpected hurdles or difficulties in launching PLEGRIDY, difficulties
obtaining or changes in the availability of reimbursement for PLEGRIDY,
problems with our manufacturing processes for PLEGRIDY, the occurrence
of adverse safety events, failure to comply with government regulation
or obtain regulatory approvals in other jurisdictions, failure to
protect our intellectual property and other proprietary rights, product
liability claims 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 U.S.
Securities and Exchange Commission (SEC (News - Alert)). Any forward-looking statements
speak only as of the date of this press release and we assume no
obligation to update any forward-looking statements, whether as a result
of new information, future events or otherwise.
1 Fishburn CS. The Pharmacology of PEGylation: Balancing PD
with PK to Generate Novel Therapeutics. Journal of Pharmaceutical
Sciences. DOI 10.1002/jps.21278, 2008.
2 NMSS. Frequently Asked Questions about Multiple Sclerosis.
2012. Accessed March 2014. Available at
3 Multiple Sclerosis International Federation, Atlas of MS
2013. Epidemiology of MS. Page 8. Date Accessed: May 14, 2014.
4 NMSS. Relapsing-Remitting MS. Date accessed: August
15, 2014. http://www.nationalmssociety.org/About-the-Society/MS-Prevalence
5 NMSS. Progressive-Relapsing MS. Date accessed:
August 15, 2014. http://www.nationalmssociety.org/What-is-MS/Types-of-MS
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