Elan Corporation : New TYSABRI Data Presented at 64th Annual AAN Meeting Highlight Biogen Idec & Elan Commitment to Improving Outcomes in Multiple Sclerosis
04/26/2012| 01:31pm US/Eastern
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-- Updates to the First Risk Stratification Algorithm That Uses
Safety Biomarker to Inform Treatment Decisions in MS --
WESTON, Mass. & DUBLIN, Apr 26, 2012 (BUSINESS WIRE) --
Biogen Idec (NASDAQ: BIIB) and
Elan Corporation, plc (NYSE: ELN) today announced
findings from several studies of TYSABRI(R) (natalizumab)
evaluating its long-term safety and efficacy in the treatment
of multiple sclerosis (MS) across the course of disease and
impact on MS-related symptoms such as fatigue. These data, as
well as data relating to the companies' risk
stratification algorithm as a way to help enable individual
benefit risk assessment for patients with MS, were accepted
for presentation at the 64th Annual Meeting of the American
Academy of Neurology (AAN).
"We continue to build on the extensive data we have for
TYSABRI and are committed to studying its long-term use and
potential effect on symptoms like fatigue, which MS patients
struggle with every day," said Douglas E. Williams,
Ph.D., executive vice president of Research and Development
at Biogen Idec. "Our research is aimed at discovering
additional ways TYSABRI can help physicians and patients best
manage the symptoms of MS and make informed and personalized
treatment choices."
Long-Term Observational Study of TYSABRI
Initial results from the TYSABRI Observational Program (TOP)
indicate that post-baseline annualized relapse rates (ARR)
after four years for patients receiving TYSABRI therapy
decreased from 1.99 at baseline to 0.28 (p<0.0001);
disability, as measured by the Expanded Disability Status
Scale (EDSS), remained stable over time. TOP is an ongoing
open-label, multicenter, observational study designed to
assess long-term outcomes in patients with
relapsing-remitting MS (RRMS) in Europe, Australia, and
Canada. TOP is expected to enroll more than 4,500 patients
who will be followed for 10 years.
Neither reduction in ARR nor stabilization of a patient's
EDSS was affected by the type of treatment they were using
before initiating TYSABRI therapy. However, ARR were lowest
in immunosuppressant (IS) therapy-naïve patients and highest
in patients who had used IS therapy (p<0.0001).
The incidence and type of serious adverse events (SAEs) seen
in these patients after long-term use was consistent with
TYSABRI's known safety profile. There were no significant
differences by baseline treatment history in the incidence of
SAEs, infection-related SAEs, or progressive multifocal
leukoencephalopathy (PML) during TYSABRI therapy, although
there was a trend of higher incidence of PML in patients with
prior IS use.
"TOP may help provide insight into the potential impact
current treatment may have on long term efficacy and safety
outcomes with TYSABRI," said Professor Ludwig Kappos,
MD, chair of Neurology, Research Group Leader Clinical
Neuroimmunology and Neurobiology, Department of Biomedicine,
University Hospital, Basel, Switzerland. "The reduction
of MS relapse and stable disability progression that we
observed with TYSABRI in the TOP study across naive and
previously treated patients was sustained after four years of
treatment."
Risk-Stratification Initiatives
Biogen Idec and Elan developed a quantitative risk
stratification algorithm to help physicians and people with
MS have more confidence in their treatment decisions when
considering TYSABRI. The algorithm provides guidance for
physicians and patients about the varying degrees of PML risk
associated with TYSABRI treatment. The variables impacting
PML risk are: anti-JCV antibody status, prior IS use, and
TYSABRI treatment duration.
"We are pleased to be able to offer MS patients and
their physicians an approach for assessing the potential
benefit-risk with TYSABRI," said Ted Yednock, executive
vice president and head of Global Research, Elan. "A
significant advancement in this area is the inclusion of
anti-JCV antibody status in the TYSABRI label as a risk
factor for developing PML, as well as the commercial
availability of the STRATIFY JCV(TM) blood test. Use of this
approach for risk stratification is supported by data
presented at AAN."
PML risk was quantified by assessing more than 92,000 MS
patients from TYSABRI post-marketing sources and clinical
studies; through September 2011 there were 159 cases of PML
among this patient population and data show PML risk was
lowest in anti-JCV antibody negative patients (no PML cases
occurred in anti-JCV antibody negative patients; with the
inclusion of one hypothetical anti-JCV antibody negative
case, the risk is less-than or equal to 0.10 cases per 1,000
patients treated). PML risk was highest in patients with all
three risk factors: anti-JCV antibody positive status; prior
immunosuppressant use; and 25-48 months of TYSABRI treatment
(10.6 cases per 1,000 patients treated). The use of anti-JCV
antibody status in this algorithm marks the first time a
safety biomarker for risk stratification has been used to
inform treatment decisions in MS and these data will be
updated during the AAN presentation.
A separate study, STRATIFY-2, an ongoing, longitudinal,
observational U.S. study, is the largest data set to date to
analyze anti-JCV antibody seroprevalence among MS patients.
Baseline anti-JCV antibody testing results from more than
35,000 MS patients who were either receiving or considering
treatment with TYSABRI showed that the overall prevalence of
anti-JCV antibodies was 53.5 percent (95% confidence interval
[CI]: 53.0%-54.0%), which is consistent with the prevalence
of anti-JCV antibodies observed in MS patients in other
clinical research. Interim results from STRATIFY-2
demonstrated prospectively that the PML incidence in
TYSABRI-treated anti-JCV antibody negative patients was
significantly lower than that in anti-JCV antibody positive
patients (anti-JCV negative = 0, CI: 0-0.34; anti-JCV
positive=1.02, CI: 0.53-1.78 [p=0.0004]). Final data from
STRATIFY-2 will further characterize PML risk in anti-JCV
antibody negative and positive patients.
TYSABRI Impact on MS-related Fatigue
Initial findings from the TYNERGY study (Effects of TYSABRI
Over 12 Months on MS Related Fatigue in Patients with RRMS)
show that TYSABRI treatment was associated with improved
MS-related fatigue. TYNERGY was a multicenter, 12-month
clinical follow-up study conducted to evaluate the effect of
TYSABRI on MS-related fatigue in patients with RRMS. Fatigue
is considered the most common symptom of MS, impacting 75-95
percent of patients. Further, 50-60 percent of MS patients
report fatigue as one of their most disabling symptoms, which
can contribute to cognitive and physical difficulties.
In the study, researchers measured MS-related fatigue at 0
and 12 months via the Fatigue Scale for Motor and Cognitive
Functions (FSMC). Results indicate that treatment with
TYSABRI impacted fatigue in patients with RRMS as evidenced
by a median reduction of the FSMC score by 9.0 points
(p<0.0001), which corresponds to an improvement from
severe to moderate fatigue. Both the motor and the cognitive
components of the FSMC showed similar improvement
(p<0.0001). Researchers noted that these first results are
promising but need further validation.
Data highlighted in this press release is featured in the
following poster and platform presentations at the AAN annual
meeting:
-
Long-Term Safety and Efficacy and Association between
Baseline Treatment History and Postbaseline Relapses in
Multiple Sclerosis Patients Treated with Natalizumab in the
TYSABRI Observational Program (TOP) (P04.134) was presented
on Wednesday, April 25, 2012
-
Updated Incidence of Progressive Multifocal
Leukoencephalopathy in Natalizumab-Treated Multiple
Sclerosis Patients Stratified by Established Risk Factors
(S41.001)-presented by Dr. Gary Bloomgren on Thursday,
April 26, 2012 from 1:00 to 1:15 p.m. CDT
-
Anti-JCV Antibody Prevalence in Patients with Relapsing
Multiple Sclerosis Receiving or Considering Treatment with
Natalizumab: Baseline Results of STRATIFY-2 (S41.002) -
presented by Dr. Sandra Richman on Thursday, April 26, 2012
from 1:15 to 1:30 p.m. CDT
-
Natalizumab Reduces Fatigue as Measured by the Fatigue
Scale for Motor and Cognitive Functions (FSMC)--First
Results from the TYNERGY trial (P07.081) - available for
viewing on Thursday, April 26, 2012 from 2:00 to 6:30 p.m.
CDT
Full session details and additional TYSABRI data presentation
listings for the 2012 AAN Annual Meeting can be found through
the AAN website (
www.aan.com/go/am12).
About TYSABRI
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 interferon or
have rapidly evolving, severe RRMS.
TYSABRI has advanced the treatment of MS patients 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 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,
including boxed warning and important safety information, and
more information about TYSABRI, please visit
www.biogenidec.com or
www.elan.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.
About Elan
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.
www.elan.com.
SOURCE: Biogen Idec and Elan Corporation, plc
Biogen Idec Contacts:
Media Contact:
Jeff Boyle, + 1 781 464 3260
or
Investor Contact:
Wendy Gabel, +1 781 464 2442
or
Elan Contacts:
Media Contact:
Niamh Lyons, +353 1 709 4176
or
Investor Contact:
Chris Burns, +1 800 252 3526
or
David Marshall, + 353 1 709 4444
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