Novartis announces extension of US regulatory priority review period for FTY720, an investigational once-daily oral multiple sclerosis therapy
(Thomson Reuters ONE) -
Novartis International AG / Novartis announces extension of US regulatory priority review period for FTY720, an investigational once-daily oral multiple sclerosis therapy processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* US Food and Drug Administration (FDA) extends priority review period by
three months to September 2010, in line with previously announced
expectations
* FDA Advisory Committee meeting scheduled for June 10 to review data from
FTY720 clinical trial program in MS
* FTY720 clinical trial program is largest ever submitted to FDA to support
approval of a new medicine in this therapeutic area
Basel, May 25, 2010 - Novartis announced today that the US Food and Drug
Administration (FDA) has extended by three months, to September 2010, its review
period for the regulatory approval of FTY720 (fingolimod). FTY720 once-daily
0.5 mg has the potential to be the first oral therapy for relapsing multiple
sclerosis (MS).
A meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory
Committee remains scheduled for June 10, 2010, to discuss the benefit/risk
profile of this new active ingredient (New Molecular Entity).
The FDA granted priority review status for FTY720 in February 2010, reducing the
standard 10-month review period to six months, which was set to end on June
21, 2010. The extension was based on the FDA's request for further analysis of
available data, which Novartis responded to and which triggered the three-month
extension. The agency did not ask for additional clinical trials. Priority
reviews are granted by the FDA for investigational medicines that could offer
significant advances beyond current treatments or where no adequate therapy
exists.
"The announcement of this revised timeline is in line with our expectations, and
reflects the comprehensive clinical program and resulting large amount of data
to be reviewed in the NDA," said Trevor Mundel, MD, Global Head of Development
at Novartis Pharma AG. "MS is a leading cause of neurological disability in
young adults and we are very committed to bringing new therapies to patients
with this disabling condition."
Data from the FTY720 MS clinical trial program, the largest ever submitted to
the FDA to support approval of a new medicine in this therapeutic area, have
demonstrated the significant benefits of FTY720 in reducing relapses in people
with MS.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "extension," "extends," "priority review," "scheduled,"
"extended," "potential," "set," "could," "expectations," "to be," "committed,"
or similar expressions, or by express or implied discussions regarding potential
marketing approvals for FTY720, or the potential timing of 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 visithttp://www.novartis.com
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[HUG#1418321]
--- End of Message ---
Novartis International AG
Postfach Basel null
WKN: 904278;ISIN: CH0012005267;
Media release (PDF): http://hugin.info/134323/R/1418321/368587.pdf
Unternehmensinformation / Kurzprofil:
Datum: 25.05.2010 - 07:15 Uhr
Sprache: Deutsch
News-ID 21366
Anzahl Zeichen: 0
contact information:
Town:
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Kategorie:
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