Biogen’s FAMPYRA® Granted Standard Marketing Authorization in European Union for Improvement of Walking in People with MS
May 24 2017 - 1:30AM
Business Wire
New Phase 3 Data Confirm Positive and
Significant Effects in Walking Improvement and Enhanced Quality of
Life
The European Commission (EC) has granted a standard marketing
authorization for FAMPYRA (prolonged-release fampridine tablets)
for walking improvement in people with multiple sclerosis (MS),
Biogen (NASDAQ: BIIB) announced today. The approval is based on the
results of the Phase 3 ENHANCE study, which confirm the clinically
meaningful benefits and safety of FAMPYRA over the long term in
people with both relapsing and progressive forms of MS. The ENHANCE
study was conducted following the EC’s conditional marketing
authorization for FAMPYRA in 2011. FAMPYRA can be used alone or
with existing MS therapies, including immunomodulatory drugs.
“Approximately 80 percent of people with MS experience walking
impairment, one of the most common issues with the disease. We
frequently hear from people living with MS that these walking
challenges affect their independence, restrict their ability to
work and negatively impact their overall quality of life,” said
Jeremy Hobart, Ph.D., consultant neurologist at Plymouth Hospitals
NHS Trust and professor of Clinical Neurology and Health
Measurement at the Plymouth University Peninsula Schools of
Medicine and Dentistry. “Results from the ENHANCE study
provided additional evidence that FAMPYRA is an effective treatment
for MS and echo what I and other clinicians have observed in
treating people with MS: FAMPYRA provides a clinically
significant improvement in walking ability as well as on broader
aspects of quality of life.”
ENHANCE Results Reaffirm Clinically Meaningful Benefits of
FAMPYRABiogen initiated ENHANCE, the third Phase 3 study for
FAMPYRA, to evaluate the long-term safety and efficacy of the
therapy in walking improvement in people with MS who have walking
disabilities (as measured by Expanded Disability Status Scores
[EDSS] of 4.0 – 7.0). ENHANCE, the largest and longest randomized
trial of FAMPYRA, included patients with primary-progressive,
secondary-progressive, progressive-relapsing and
relapsing-remitting MS. Results, first reported in 2016, show that
over 24 weeks:
- Significantly more FAMPYRA patients
achieved a clinically meaningful improvement in walking ability
compared to patients taking placebo (43.2% vs. 33.6%, respectively;
p=0.006), as measured by the self-reported 12-Item MS Walking Scale
(MSWS-12), the primary endpoint.
- Significantly more FAMPYRA patients
experienced improved mobility compared to those taking placebo, as
measured by a mean improvement in the clinician-reported timed up
and go (TUG) speed from baseline (43.4% vs. 34.7%, respectively;
p=0.03).
- FAMPYRA patients demonstrated greater
improvements in the Multiple Sclerosis Impact Scale-29 (MSIS-29)
physical score, a self-reported measure of the physical impact of
MS, than those treated with placebo (-8.00 vs. -4.68, respectively;
p<0.001).
- The positive effects of FAMPYRA on
improving balance and upper limb dexterity compared to placebo were
also observed; however, these results were not statistically
significant.
- The benefit-risk profile of FAMPYRA
remains positive.
“FAMPYRA is a valued medication among MS patients and physicians
that addresses one of the most prevalent and disruptive symptoms of
the disease. For the past several years, Biogen has been focused on
ensuring that FAMPYRA is available to MS patients in Europe who
experience walking disability,” said Ferenc Tracik, M.D., vice
president, EU+ Medical Affairs. “The approval of the standard
marketing authorization for FAMPYRA is validation of the
substantial difference this therapy has made on the lives of people
with MS, and speaks to our deep, long-standing commitment to the MS
community.”
About FAMPYRA®FAMPYRA® (prolonged-release fampridine
tablets) is a treatment indicated to improve walking in adult
patients with MS. Biogen has a license from Acorda Therapeutics,
Inc. to develop and commercialise FAMPYRA in all markets outside
the United States.
FAMPYRA is the first treatment to both address the unmet
medical need of walking improvement in adults living with MS, and
demonstrate clinical efficacy in adults with MS. FAMPYRA can
be used alone or in combination with disease modifying therapies,
including immunomodulatory drugs. In clinical trials, patients
responding to FAMPYRA had an average increase in walking speed of
25 percent and FAMPYRA was shown to provide a clinically meaningful
improvement in walking.
The highest incidence of adverse reactions identified from
placebo-controlled trials in MS patients with FAMPYRA, given at the
recommended dose, was urinary tract infection (in
approximately 12% of patients), although infection was often not
proven by culture. Adverse drug reactions identified were mainly
divided between neurological disorders (such as insomnia, balance
disorder, dizziness, paraesthesia, headache, anxiety and tremor)
and gastrointestinal disorders (including nausea, vomiting,
dyspepsia and constipation). Other common adverse drug reactions
reported were asthenia, back pain, pharyngolaryngeal pain and
dyspnea. In post-marketing experience, there have been reports of
seizures, hypersensitivity reactions (including anaphylaxis) and
exacerbations of trigeminal neuralgia (TN) in patients with a
history of TN. Because these reactions are reported voluntarily
from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal
relationship to drug exposure.
For further information on FAMPYRA in your country
please click here.
U.S. residents: For information, please visit Acorda
Therapeutics.
About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers innovative therapies
worldwide for people living with serious neurological and
neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in
biotechnology and today the Company has the leading portfolio of
medicines to treat multiple sclerosis, has introduced the first and
only approved treatment for spinal muscular atrophy, and is at the
forefront of neurology research for conditions including
Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral
sclerosis. Biogen also manufactures and commercializes biosimilars
of advanced biologics. For more information, please
visit www.biogen.com. Follow us on social media
– Twitter, LinkedIn, Facebook, YouTube.
Safe HarborThis press release contains forward-looking
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including
statements relating to the potential benefits, safety and efficacy
of FAMPYRA and the results of certain real-world data. These
forward-looking statements may be accompanied by words such as
“anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,”
“intend,” “may,” “plan,” “potential,” “possible,” “will” and other
words and terms of similar meaning. You should not place undue
reliance on these statements or the scientific data presented. Drug
development and commercialization involve a high degree of risk.
These statements involve risks and uncertainties that could cause
actual results to differ materially from those reflected in such
statements, including, without limitation: unexpected concerns that
may arise from additional data or analysis; regulatory authorities
may require additional information or further studies, or may fail
to approve or may delay approval of Biogen’s drug candidates or
expansion of product labeling; or Biogen may encounter other
unexpected hurdles which may be impacted by, among other things,
the occurrence of adverse safety events, failure to obtain
regulatory approvals in certain jurisdictions, failure to protect
intellectual property and other proprietary rights, product
liability claims or third party collaboration risks. The foregoing
sets forth many, but not all, of the factors that could cause
actual results to differ from our expectations in any
forward-looking statement. Investors should consider this
cautionary statement, as well as the risk factors identified in
Biogen’s most recent annual or quarterly report and in other
reports Biogen has filed with the U.S. Securities and Exchange
Commission. 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, whether as a result of new information,
future developments or otherwise.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170523005917/en/
BiogenMEDIA CONTACT:Lindsey Smith, +1
781-464-3260public.affairs@biogen.comorINVESTOR CONTACT:Mike
Hencke, +1 781-464-2442IR@biogen.com
Biogen (NASDAQ:BIIB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Biogen (NASDAQ:BIIB)
Historical Stock Chart
From Sep 2023 to Sep 2024