FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS
Novartis International AG / FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Committee voted in favor of approval of FTY720 (fingolimod), as treatment in
relapsing remitting multiple sclerosis, affirming the drug's positive
benefit/risk profile
* FTY720, potentially first in a new class of MS therapy, represents a
significant advance as an efficacious oral treatment for people with
relapsing remitting MS
* Committee recommended post marketing collection of additional safety data
and evaluation of a lower dose
Basel, June 10, 2010 - Today, an advisory committee of the US Food and Drug
Administration (FDA) recommended approval of FTY720 (fingolimod) for the
treatment of patients with relapsing multiple sclerosis, the most common form of
the disease. The FDA has the option of seeking the advice of one of its advisory
committees as it reviews and decides whether to approve a new treatment. The
committee voted unanimously that FTY720 demonstrated substantial efficacy in
treating relapsing remitting MS and that safety of the proposed 0.5 mg dose
justified approval.
"This is an encouraging and important milestone for the MS community," said Dr.
Patricia O'Looney, Vice President, Biomedical Research at the National Multiple
Sclerosis Society. "We believe that a treatment that reduces relapses and slows
disability progression in a convenient oral formulation could encourage more
people with MS to initiate treatment in the course of this life-long disease."
The committee evaluated data from the largest clinical trial program( )ever
submitted to the FDA as part of an MS new drug application. This study data
provided evidence of superior efficacy of FTY720 over one of the most commonly
prescribed treatments, interferon beta-1a IM (Avonex(®)), and to placebo, in
reducing relapses and brain lesions (a measure of disease activity)[1],[2]. In
addition, the two-year placebo-controlled study showed FTY720 significantly
delayed disability progression[2]. The advisory committee discussed monitoring
parameters for the therapeutic use of FTY720 and also recommended post-marketing
collection of additional safety data and evaluation of a lower dose.
"Novartis is pleased by the committee's vote to recommend FDA approval of FTY720
as a treatment that has demonstrated substantial efficacy for relapsing
remitting multiple sclerosis. The committee's positive vote affirms the
favorable benefit/risk profile of FTY720 and we will work closely with the FDA
as it finalizes its review of our new drug application," said Trevor Mundel, MD,
Global Head of Development at Novartis Pharma AG. "If approved, FTY720 will
offer patients an effective treatment in the convenience of a pill and we look
forward to making this innovative therapy available for people with MS."
If approved, FTY720 would potentially be the first oral therapy for treating
relapsing MS. FTY720 would be the first in a new class of therapies developed
for relapsing MS called sphingosine1-phosphate receptor (S1PR) modulators, which
work by retaining certain immune cells (lymphocytes) in the lymph nodes,
preventing them from reaching the central nervous system and causing damage.
This lymphocyte retention is reversible, allowing circulating lymphocytes to
regain normal levels if treatment is stopped.
The FDA granted FTY720 priority review status in February 2010, reducing the
standard 10-month review to six months. In May, the FDA extended the priority
review period by three months to September 2010.
The safety profile of FTY720 has been well studied and includes more than 4,500
patient years of experience, with some patients in their seventh year of
treatment. In Phase III studies FTY720-related adverse events included
transient, dose-related, generally asymptomatic heart rate reduction and
infrequent transient AV conduction block at treatment initiation, mild (1-3 mm
Hg) blood pressure increase, macular edema (more common with 1.25 mg than the
0.5 mg target dose), and generally asymptomatic, reversible elevation of liver
enzymes[1],[2].
The rates of infections overall, including serious infections, were comparable
among treatment groups, although a slight increase in lung infections (primarily
bronchitis) was seen in patients treated with FTY720. The number of malignancies
reported across the two studies was small with comparable rates between the
FTY720 and control groups[1],[2].
Multiple sclerosis is thought to be an autoimmune disease of the central nervous
system that is chronic, progressive and often disabling. It affects over
400,000 Americans and up to 2.5 million people worldwide.( )The most common form
of the disease,( )relapsing MS, is characterized by exacerbations or "flare-ups"
interspersed with periods of disease remission. Typically, MS strikes in early
adulthood between the ages of 20 and 40, and affects women twice as frequently
as men.( )
Avonex(® )is a registered trademark of Biogen Idec.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommends," "potentially," "recommended," "believe,"
"could," "recommend," "will," "look forward." "would," "priority review," or
similar expressions, or by express or implied discussions regarding potential
marketing approvals for FTY720 or the timing of any such approvals, or regarding
potential future revenues from FTY720. 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 with FTY720 to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that FTY720
will be approved for sale in any market or at any particular time. Nor can there
be any guarantee that FTY720 will achieve any particular levels of revenue in
the future. In particular, management's expectations regarding FTY720 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 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com .
References
[1] Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing
Multiple Sclerosis. N Eng J Med 2010; 362:402-415.
[2] Kappos L. et al. A Placebo-Controlled trial of Oral Fingolimod in Relapsing
Multiple Sclerosis. N Eng J Med 2010; 352:5.
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