Novartis amends current US FDA application for Afinitor® to seek indication for advanced neuroendocrine tumors of pancreatic origin
(Thomson Reuters ONE) -
Novartis International AG /
Novartis amends current US FDA application for Afinitor® to seek indication for
advanced neuroendocrine tumors of pancreatic origin
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Basel, April 8, 2011 - Novartis announced today that it has updated its
supplemental New Drug Application (sNDA) to the US Food and Drug Administration
(FDA) for Afinitor(®) (everolimus) tablets. The submission has been amended to
only seek approval for the treatment of patients with advanced neuroendocrine
tumors (NET) of pancreatic origin. The original submission included a proposed
indication for patients with advanced NET of gastrointestinal, lung or
pancreatic origin.
The decision by Novartis was based on feedback from the FDA. Novartis remains
committed to patients with advanced NET and will continue to conduct studies in
patients with advanced carcinoid tumors, where there is a critical unmet need.
The FDA requested that the application be reviewed by the Oncologic Drugs
Advisory Committee (ODAC) on April 12, 2011. The FDA can seek the advice of its
advisory committees as it reviews and decides whether to approve treatments,
however, the recommendations put forth by the group are advisory in nature and
do not always reflect the final decisions of the FDA[1],[2]. There is also the
potential that the discussion and outcome of this meeting could result in the
FDA extending the review period.
Earlier this year, the FDA granted everolimus priority review designation for
the application of advanced NET of GI, lung or pancreatic origin. Priority
review status is granted to therapies that offer major advances in treatment or
provide a treatment where no adequate therapy exists. This status accelerates
the standard review time for everolimus from 10 to six months[3]. The
application is based on data from the RADIANT (RAD001 In Advanced Neuroendocrine
Tumors) trial program.
Worldwide regulatory filings for everolimus as a treatment for advanced NET of
gastrointestinal, lung or pancreatic origin are being reviewed by health
authorities. For more information about Afinitor please visit
www.afinitor.com/global.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "seek," "proposed," "committed," "will," "potential,"
"could," "priority review," or similar expressions, or by express or implied
discussions regarding potential submissions or approvals for new indications or
labeling for Afinitor, or regarding the potential timing of any such approvals,
or regarding potential future revenues from Afinitor. 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 Afinitor to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that Afinitor will be submitted or approved for any additional indications or
labeling in any market. Nor can there be any guarantee that Afinitor will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding Afinitor 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; the company's
ability to obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general public
pricing pressures; 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 2010, the Group's continuing operations achieved net sales of
USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding
impairment and amortization charges) was invested in R&D throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 119,000 full-time-equivalent associates (including 16,700 Alcon
associates) and operate in more than 140 countries around the world. For more
information, please visithttp://www.novartis.com.
References
1. US Food and Drug Administration. Advisory Committees. Oncologic Drugs
Advisory Committee. Available at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
Drugs/OncologicDrugsAdvisoryCommittee/default.htm. Accessed April 2011.
2. US Food and Drug Administration. The Federal Advisory Committee Act.
Available at
http://www.fda.gov/downloads/AdvisoryCommittees/AboutAdvisoryCommittees/
LawsRegulationsGuidance/UCM154704.doc. Accessed April 2011.
3. US Food and Drug Administration. Fast Track, Accelerated Approval and
Priority Review. Available at
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/
speedingaccesstoimportantnewtherapies/ucm128291.htm. Accessed April 2011.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Denise Brashear
Novartis Global Media Relations Novartis Oncology
+41 61 324 7999 (direct) +1 862 778 7336
+41 79 593 4202 (mobile) denise.brashear(at)novartis.com
eric.althoff(at)novartis.com
e-mail: media.relations(at)novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944
Susanne Schaffert +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
--- End of Message ---
Novartis International AG
Postfach Basel
WKN: 904278;ISIN: CH0012005267;
Media release (PDF):
http://hugin.info/134323/R/1504913/439849.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novartis International AG via Thomson Reuters ONE
[HUG#1504913]
Unternehmensinformation / Kurzprofil:
Datum: 08.04.2011 - 18:00 Uhr
Sprache: Deutsch
News-ID 53339
Anzahl Zeichen: 8922
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 208 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis amends current US FDA application for Afinitor® to seek indication for advanced neuroendocrine tumors of pancreatic origin"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
