Novartis gains positive CHMP opinion for Gilenya®, first oral multiple sclerosis treatment recommended for approval in the European Union
(Thomson Reuters ONE) -
Novartis International AG /
Novartis gains positive CHMP opinion for Gilenya®, first oral multiple sclerosis
treatment recommended for approval in the European Union
Processed and transmitted by Thomson Reuters.
The issuer is solely responsible for the content of this announcement.
* Gilenya recommended in the EU for people with highly active relapsing-
remitting MS despite treatment with beta interferon, or in patients with
rapidly evolving severe relapsing-remitting MS
* Gilenya showed superior efficacy to interferon beta-1a IM, a commonly
prescribed treatment, reducing relapses by 52% (p<0.001)at one year
* Two-year, placebo-controlled study demonstrated that Gilenya significantly
reduced the risk of disability progression
Basel, January 21, 2011 - The European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion for
Gilenya(®) (fingolimod) 0.5 mg daily as a disease modifying therapy in patients
with highly active relapsing-remitting multiple sclerosis (MS) despite treatment
with beta interferon, or in patients with rapidly evolving severe relapsing-
remitting MS.
The CHMP opinion was based on the largest clinical trial program( )submitted to
date for a new MS drug, and included data from clinical studies showing
significant efficacy in reducing relapses, the risk of disability progression,
and the number of brain lesions detected by magnetic resonance imaging (MRI), a
measure of disease activity[1],[2].
"More than 500,000 people in the EU live with MS, a debilitating neurological
condition that involves an unpredictable, life-long progression of complex
symptoms," commented John Golding, President, European Multiple Sclerosis
Platform (EMSP). "The first available oral MS treatment that offers significant
efficacy for appropriate patients is a welcome alternative."
The CHMP recommendation forms the basis for a European Commission licensing
decision, which is expected in approximately three months.
"We're pleased with today's recommendation by the CHMP because it means patients
in Europe with highly active relapsing-remitting MS could soon benefit from
Gilenya's significant efficacy in a once-daily capsule," said David Epstein,
Division Head of Novartis Pharmaceuticals. "Novartis is committed to providing
innovative medicines like Gilenya to patients with multiple sclerosis, and we
look forward to working with countries across Europe towards this goal."
About Gilenya
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a
new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. In
MS, the immune system damages the covering that protects nerve fibers in the
central nervous system (CNS), which includes the brain and spinal cord. The
novel mechanism of Gilenya is thought to work by reducing the immune system's
attack on the CNS by retaining certain white blood cells (lymphocytes) in the
lymph nodes. This prevents the white blood cells from reaching the CNS, where
they could potentially attack the protective covering around the nerve fibers,
resulting in less inflammatory damage to the nerve cells.( )The white blood cell
retention is reversible if Gilenya treatment is stopped.
The EU application included data showing Gilenya 0.5 mg reduced relapses by 52%
(P<0.001) at one year compared with interferon beta-1a IM (Avonex(®)), one of
the most commonly prescribed treatments for MS Data from a two-year placebo-
controlled study showed a reduction in the risk of disability progression among
Gilenya patients (30% reduction confirmed at three-month follow-up visit P=0.02,
compared with placebo)[2]. In clinical studies, treatment with Gilenya also
resulted in statistically significant reductions in brain lesion activity as
measured by MRI.
Gilenya has been studied in more than 4000 MS patients. The most common side
effects are headache, liver enzyme elevations, influenza, diarrhea, back pain,
and cough. Other Gilenya-related side effects include transient, generally
asymptomatic, heart rate reduction and atrioventricular block upon treatment
initiation, mild blood pressure increase, macular edema, and mild
bronchoconstriction.[1],[2]
The rates of infections overall, including serious infections, were comparable
among treatment groups, although a slight increase in lower respiratory tract
infections (primarily bronchitis) was seen in patients treated with Gilenya. The
number of malignancies reported across the clinical trial program was small,
with comparable rates between the Gilenya and control groups.[1],[2]
Avonex(® )is a registered trademark of Biogen Idec.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommended," "recommendation," "expected," "could,"
"committed," "look forward," "potentially," or similar expressions, or by
express or implied discussions regarding potential additional marketing for
Gilenya, or regarding the timing of any such approvals, or regarding potential
future revenues from Gilenya. 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 Gilenya to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Gilenya
will be approved for sale in any additional markets, or at any particular time.
Nor can there be any guarantee that Gilenya will achieve any particular levels
of revenue in the future. In particular, management's expectations regarding
Gilenya 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 102,000 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 et al.Oral Fingolimod vs. Intramuscular Interferon in Relapsing
Multiple Sclerosis. N Engl J Med. Vol.362 No.5, Feb 4, 2010 (printed version)
[2] Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing
Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010 (printed version).
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Julie Morrow
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 696 7581 (direct)
+41 79 593 4202 (mobile) +41 79 357 3259 (mobile)
eric.althoff(at)novartis.com julie.morrow(at)novartis.com
e-mail: media.relations(at)novartis.com
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please
contact:journalisthelp(at)thenewsmarket.com.
Novartis Investor Relations
Central phone: +41 61 324 7944
Susanne Schaffert +41 61 324 3769 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/1481425/416730.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#1481425]
Unternehmensinformation / Kurzprofil:
Datum: 21.01.2011 - 13:00 Uhr
Sprache: Deutsch
News-ID 50631
Anzahl Zeichen: 11422
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 228 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis gains positive CHMP opinion for Gilenya®, first oral multiple sclerosis treatment recommended for approval in the European Union"
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).
