[May 24, 2017] |
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Biogen's FAMPYRA® Granted Standard Marketing Authorization in European Union for Improvement of Walking in People with MS
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 FAMPYRA Biogen
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:
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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.
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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).
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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).
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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.
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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 Affars. "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 Biogen Through 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.
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Safe Harbor This 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.
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