Novartis confirms positive benefit-risk profile of Gilenya® following CHMP review and label update recommendation
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Novartis confirms positive benefit-risk profile of Gilenya® following CHMP
review and label update recommendation
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* Revised label agreed between Novartis and the CHMP provides further guidance
to healthcare providers regarding treatment initiation with Gilenya in MS
patients in the EU
* Patients should have ECG before and six hours after the first-dose, with
hourly blood pressure and heart rate measures; Continuous ECG recommended
* Caution regarding use in patients who may be less tolerant of or are more
likely to develop significantly slowed or abnormal heart rate
Basel, April 20, 2012 - Novartis announced today that the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has
confirmed a positive benefit-risk profile of once-daily oral Gilenya®
(fingolimod). Novartis and the CHMP have agreed to recommended updates to the
product information in the European Union in order to provide further guidance
to healthcare providers regarding treatment initiation with Gilenya in MS
patients. The changes follow the Article 20 review by the EMA announced in
January 2012.
In the European Union, all MS patients initiating treatment with Gilenya should
have an electrocardiogram (ECG) and a blood pressure measurement prior to the
first dose of the medicine and after the six-hour first-dose monitoring period.
Blood pressure and heart rate should be measured every hour during this period,
and continuous ECG monitoring is recommended for a minimum of six hours
following the first dose.
"We believe that Gilenya is a valuable treatment option for many patients with
relapsing remitting MS, and we welcome the confirmation of the positive benefit-
risk profile of the drug which also supports our continued belief of the
blockbuster potential of Gilenya," said David Epstein, Division Head of Novartis
Pharmaceuticals. "MS is a devastating chronic disease that affects more than
2.1 million people worldwide, and patients need effective treatment options."
As of February 2012, approximately 36,000 patients have been treated with
fingolimod in clinical trials and in the post-marketing setting, some up to
seven years, and currently there is approximately 34,000 patient years of
exposure. In the European Union, Gilenya is approved for people with highly
active relapsing-remitting MS despite treatment with beta interferon, or in
patients with rapidly evolving severe relapsing-remitting MS.
More about the CHMP recommended label update
Extended ECG monitoring is required after first-dose of Gilenya for patients who
have very low or their lowest measured heart rate at the six hour time point,
and in patients who have symptomatic bradycardia (low heart rate) or ECG
abnormalities at any time during the six hour monitoring.
In addition, the recommended label update in the European Union cautions against
use in patients who may be less tolerant of or are more likely to develop
significantly slowed or abnormal heart rate because of certain underlying
conditions or concomitant medications. If treated, these patients would require
overnight monitoring. Experience with the use of Gilenya in such patients was
limited in the pivotal clinical trials.
The new first-dose observation recommendations do not affect patients who are
already taking Gilenya. If therapy is interrupted for more than two weeks,
patients should undergo the new recommended monitoring upon treatment re-
initiation. Patients should not make any changes to any medications they are
taking, including Gilenya, without consulting their doctor.
The CHMP labeling recommendations will be reviewed by the European Commission
with a final decision expected in June 2012. Novartis will inform physicians in
the European Union of the changes in the product information in the EU via a
Direct Healthcare Provider Communication (DHPC) by end of April 2012.
About Gilenya(®) (fingolimod)
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a
new class of compounds called sphingosine 1-phosphate receptor (S1PR)
modulators. It has demonstrated superior efficacy compared to Avonex(®)
(interferon-beta-1a IM), a commonly prescribed treatment, showing a 52% relative
reduction in annualized relapse rate (primary endpoint) and a 40% relative
reduction in the rate of brain atrophy (secondary endpoint) at one year in a
pivotal head-to-head trial in patients with relapsing-remitting multiple
sclerosis. In a recent sub-analysis, Gilenya showed a 61% relative reduction in
annualized relapse rate compared to interferon-beta-1a (IM) at one year in
subgroups of patients with highly active relapsing-remitting MS patients
previously treated with interferon.
Gilenya is generally a highly effective once-daily oral MS treatment without
label restrictions specific to treatment duration. In clinical trials it was
generally well tolerated with a manageable safety profile, and there is
increasing experience of Gilenya's long-term effectiveness and safety profile,
with more than 36,000 patients having been treated as of February 2012 in
clinical trials and in the post-marketing setting, 2,400 patients having been on
treatment for more than two years. In clinical trials, the most common side
effects were headache, liver enzyme elevations, influenza, diarrhea, back pain,
and cough. Other Gilenya-related side effects included transient, generally
asymptomatic, heart rate reduction and atrioventricular block upon treatment
initiation, mild blood pressure increase, macular edema, and mild
bronchoconstriction.
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.
As part of the Novartis commitment to transparency, the Gilenya Information
Center has recently launched. For more information please visit the Gilenya
information site at http://www.novartis.com/newsroom/product-related-info-
center/gilenya.shtml.
Note to investors
Novartis has scheduled a conference call with members of the financial community
to discuss this announcement on Friday, April 20, at 15:00 Central European
Time. A simultaneous live webcast may be accessed by visiting the Novartis
website at www.novartis.com.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommendation," "should," "recommended," "potential,"
"will," "recommendations," "expected," or similar expressions, or by express or
implied discussions regarding potential new labeling for Gilenya 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 any additional labeling in any market, 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, including the
finalization of the EU review of the CHMP labeling recommendations; 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; unexpected
manufacturing issues; 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 innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
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