FDA Approves Extavia
US FDA Approves Extavia - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease
Basel, August 17, 2009 - The US Food and Drug Administration (FDA) has
approved Extavia (interferon beta-1b), the first in a new planned portfolio of
multiple sclerosis (MS) medicines from Novartis to help patients
manage this devastating disease.
Extavia is approved by the FDA for the treatment
of relapsing forms of MS to reduce the frequency of clinical
exacerbations. The therapy is also indicated for patients who have
experienced a first clinical episode of MS and have features
consistent with the disease as shown by magnetic resonance imaging
(MRI)[4].
The same medicinal product as Betaseron*, Extavia offers patients and physicians a new
branded version of interferon beta-1b, a first-line
disease-modifying therapy that has been a standard-of-care for MS
in the US for more than 16 years[1]. Extavia will be marketed by
the Pharmaceuticals Division of Novartis.
"Interferon is a mainstay of treatment in MS,"
said Doug Jeffery, MD, Associate Professor at Wake Forest
University Baptist Medical Center in Winston-Salem, North Carolina,
USA. "With the approval of Extavia, patients have another option
with a well-established safety and efficacy profile to help manage
this disease."
MS is estimated to affect approximately 400,000
patients in the US[2], of whom more than 80% have
relapsing-remitting MS[5]. MS is one of the most common causes of
neurological disability in young adults. It is a chronic autoimmune
disease in which the body's immune system attacks the myelin
sheath, or protective tissue surrounding the nerve fibers that
carry electrical signals in the brain[6]. The destruction of myelin
causes problems with muscle control and strength, vision, balance,
sensation and mental function[7].
"Novartis has been a leader in neuroscience for
more than 50 years, having pioneered a number of breakthrough
therapies which remain important treatments to this day," said Joe
Jimenez, CEO of the Novartis Pharmaceuticals Division. "We are
committed to providing new approaches to MS care, and the FDA
approval of Extavia marks the beginning of our long-term commitment
to the MS community in the US."
Extavia will be available to patients in the US
this fall. Along with their prescription for Extavia, patients will
be given access to a support program including a nurse helpline,
one-on-one injection training and reimbursement support services.
Extavia patients will have an autoinjector available to them from
Novartis.
"MS is unpredictable and can be difficult to
manage," said Aaron Miller, MD, Professor of Neurology at Mount
Sinai School of Medicine in New York, USA. "Support programs are an
essential element to help patients and physicians effectively
manage this complicated disease."
MS typically presents in relapsing forms
involving acute self-limiting attacks of neurological dysfunction
(known as exacerbations or relapses), followed by complete or
partial restoration of function[6].
Interferon beta-1b has been shown to reduce
annualized relapse rates by 34% (p=0.0001)[8], with patients nearly
twice as likely to remain relapse-free for more than two years
compared to those receiving placebo (31% vs. 16%, p=0.007)[8]. In
addition, treatment with interferon beta-1b may slow disease
progression[9]. After two years, almost three-quarters of patients
who experienced a single episode of neurological disease lasting 24
hours or more did not progress to clinically definite MS[10].
In the European Union Extavia is available in 12
countries and is approved for relapsing-remitting MS as well as
early MS (defined as a single demyelinating event with an active
inflammatory process) and a steadily worsening form of the disease
known as secondary progressive MS with relapses.
* Novartis gained the rights to seek approval
for its own branded version of interferon beta-1b through
agreements with Bayer Schering, the company that markets
Betaseron.
Betaseron is marketed under the name of
Betaferon® outside the US. Betaseron and Betaferon are
registered trademarks of Bayer Schering Pharma AG.
Disclaimer
The foregoing release contains forward-looking
statements that can be identified by terminology such as "planned,"
"may," "committed," "long-term commitment," "will," "can,"
"likely," or similar expressions, or by express or implied
discussions regarding potential future multiple sclerosis products
or regarding potential future revenues from Extavia or other
multiple sclerosis products. You should not place undue reliance on
these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve
known and unknown risks, uncertainties and other factors that may
cause actual results to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that any additional Novartis
multiple sclerosis products will be approved for sale in any
market. Nor can there be any guarantee that Extavia or such other
products will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding such
products could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing
clinical data; competition in general; government, industry and
general public pricing pressures; the company's ability to obtain
or maintain patent or other proprietary intellectual property
protection; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as
recorded in the Group's consolidated balance sheet, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Should one or more
of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected. Novartis
is providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that
address the evolving needs of patients and societies. Focused
solely on healthcare, Novartis offers a diversified portfolio to
best meet these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines, diagnostic tools and consumer
health products. Novartis is the only company with leading
positions in these areas. In 2008, the Group's continuing
operations achieved net sales of USD 41.5 billion and net income of
USD 8.2 billion. Approximately USD 7.2 billion was invested in
R&D activities throughout the Group. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 99,000
full-time-equivalent associates and operate in more than 140
countries around the world.
References
- FDA approves Betaseron® for use after the first event suggestive of multiple sclerosis [press release]. Wayne, NJ: Berlex: 23 October 2006.
- National Multiple Sclerosis Society website./div>
- Multiple Sclerosis International Federationwebsite.
- Extavia Prescribing Information, August 14,2009.
- Habermann, T. and Amit K. Ghosh ed. Mayo Clinic Internal Medicine Concise Textbook.Florence, KY: Informa HealthCare, 2007
- National Multiple Sclerosis Society website.
- Multiple Sclerosis International Federationwebsite.
- The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Neurology. 1993;43:655-661.
- Betaseron Product Label
- Kappos L, Freedman MS, Polman CH, et al.Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67:1242-1249.
Posted: August 2009
Extavia (interferon beta-1b) FDA Approval History
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