Two New Analyses Reinforce Consistent Efficacy of Novartis Therapy Gilenya Across Wide Range of Relapsing MS Patients
• Data from FREEDOMS study show Gilenya reduced relapses in
patients who discontinued another MS therapy due to side effects or
inadequate efficacy
• Analyses of five clinical studies show Gilenya, reduced
relapse rates nearly 50% and increased proportion of patients free
from relapse
• More than 36,000 patients worldwide have been treated with
Gilenya, the first once-daily oral drug approved to treat relapsing
forms of MS
East Hanover, NJ, May 31, 2012 – A new post-hoc analysis of
data from the FREEDOMS study demonstrated that the efficacy of
Gilenya™ (fingolimod) in patients with relapsing-remitting
multiple sclerosis (MS) who had previously been treated with
another MS therapy, was generally consistent with the efficacy seen
among the total population included in the clinical trial. An
additional analysis looked at the efficacy of Gilenya compared to
interferon beta 1a IM or placebo across three Phase III and two
Phase II studies, representing more than 4,000 patients in multiple
geographies. These data are being presented at the Consortium of
Multiple Sclerosis Centers (CMSC) annual meeting, May 30-June 2 in
San Diego.
The pivotal, two-year, phase III FREEDOMS study included 1,272
patients with relapsing-remitting MS and examined the safety and
efficacy of Gilenya (1.25 mg and 0.5 mg) compared to placebo.
Gilenya 0.5 mg demonstrated a statistically significant 54%
reduction in annualized relapse rate (ARR) compared to placebo at
two years. The new post-hoc analysis assessed the efficacy of
Gilenya compared to placebo among patients who had received
previous treatment with disease modifying therapies (DMTs) and
showed that Gilenya 0.5 mg reduced the ARR compared to placebo in
all cases.
Among the patients who discontinued their prior treatment due to
inadequate efficacy, Gilenya 0.5 mg reduced the ARR by 69% compared
to placebo (Gilenya 0.5 mg, n=41, ARR=0.291; placebo, n=38,
ARR=0.931). For patients who stopped their prior treatment due to
side effects, Gilenya 0.5 mg reduced the ARR by 36% compared to
placebo (Gilenya 0.5 mg, n=73, ARR=0.329; placebo, n=79,
ARR=0.517). Patients also demonstrated reductions in relapses
compared to placebo regardless of duration of prior DMT treatment.
Gilenya 0.5 mg also reduced annualized relapse rate compared to
placebo for patients who had never previously received DMTs for
their MS [placebo 0.456, Gilenya 0.166, P<0.0001.]
“Treatment side effects or suboptimal response often leads to
switching disease modifying therapy (DMT) for patients with
relapsing forms of multiple sclerosis,” said Barry Singer,
MD, Director of The MS Center for Innovations in Care at Missouri
Baptist Medical Center. “These data add to the growing body
of evidence that supports the role of Gilenya as an efficacious
treatment option for patients previously treated with other
DMTs."
Novartis is also presenting an analysis of five studies assessing
Gilenya (0.5 mg, 1.25 mg and 5.0 mg) in more than 4,000 patients
with relapsing-remitting MS across diverse geographies, including
the United States, Canada, Europe and Japan. Patients treated with
Gilenya 0.5 mg for duration of six months to two years showed a
reduction in ARR by nearly 50% vs placebo and interferon beta-1a IM
[FREEDOMS: 54% p<0.05; FREEDOMS II: 48% p<0.05; TRANSFORMS:
52% p<0.05]. Gilenya 0.5 mg also increased the proportion of
patients who remained free from relapse during the study period
when compared to placebo [FREEDOMS: 70.4% to 45.6%] and to
interferon beta-1a IM [TRANSFORMS: 82.6% to 69.3%]. The proportion
of patients who were relapse-free at two years in the FREEDOMS II
study has not yet been reported.
About Gilenya™ (fingolimod)
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the
first in a new class of drugs called sphingosine 1-phosphate
receptor (S1PR) modulators. Gilenya works by targeting S1P
receptors that exist in the cardiovascular, central nervous and
immune systems. In targeting the S1P receptor, initiation of
treatment with Gilenya is known to be associated with bradycardia
(slowing of the heart rate) and atrioventricular (AV) block (a
problem with electrical impulse conduction in the heart).
Gilenya is an effective prescription medicine proven to decrease
the number of MS flare-ups (relapses) and slow down the physical
problems MS causes. In a two-year study, Gilenya reduced annualized
MS relapses by 54% (0.18 vs. 0.40; p<0.001) and 52% (0.16 vs.
0.33; p<0.001) at one year, when compared with placebo and
interferon beta-1a IM, respectively. Additionally, Gilenya showed a
30% reduction in the risk of 3-month confirmed disability
(p<0.05; key secondary endpoint) compared to placebo.
Indication
GILENYA is a prescription medicine used to treat relapsing forms of
multiple sclerosis (MS) in adults. GILENYA can decrease the number
of MS flare-ups (relapses). GILENYA does not cure MS, but it can
help slow down the physical problems that MS causes.
Important Safety Information
You should not take GILENYA if in the last 6 months you experienced
heart attack, unstable angina, stroke or warning stroke, or certain
types of heart failure. Do not take GILENYA if you have an
irregular or abnormal heartbeat (arrhythmia) or if you take
medicines that change your heart rhythm.
GILENYA may cause serious side effects such as:
• Slow heart rate, especially after your first dose. A test to
check the electrical activity of your heart (ECG) will be performed
before and six hours after your first dose. Your pulse and blood
pressure should be checked every hour while you stay in a medical
facility during this time. If your heart rate slows down too much,
you might feel dizzy or tired, or feel like your heart is beating
slowly or skipping beats. Symptoms can happen up to 24 hours after
your first dose. After 6 hours, if your ECG shows any heart
problems or if your heart rate is still too low or continues to
decrease, you will continue to be watched by a health care
professional. If you have any serious side effects after your first
dose, especially those that require treatment with other drugs, you
will stay in a medical facility to be watched overnight and for at
least 6 hours after your second dose of GILENYA the next day. If
you experience slow heart rate, it will usually return to normal
within 1 month. Call your doctor or go to the nearest emergency
room right away if you have any symptoms of a slow heart rate. If
you stop taking GILENYA for more than 14 days, you will need to
repeat this observation.
• Increased risk of serious infections. GILENYA lowers the
number of white blood cells (lymphocytes) in your blood. This will
usually go back to normal within 2 months of stopping GILENYA. Your
doctor may do a blood test before you start GILENYA. Increased risk
of infection was seen with doses higher than the approved dose (0.5
mg). Two patients died who took higher-dose GILENYA (1.25 mg)
combined with high-dose steroids. Call your doctor right away if
you have fever, tiredness, body aches, chills, nausea, or
vomiting.
• Macular edema, a vision problem that can cause some of the
same vision symptoms as an MS attack (optic neuritis), or no
symptoms. Macular edema usually starts in the first 3 to 4 months
after starting GILENYA. Your doctor should test your vision before
you start GILENYA; 3 to 4 months after you start GILENYA; and any
time you notice vision changes. Vision problems may continue after
macular edema has gone away. Your risk of macular edema may be
higher if you have diabetes or have had an inflammation of your eye
(uveitis). Call your doctor right away if you have blurriness,
shadows, or a blind spot in the center of your vision; sensitivity
to light; or unusually colored vision.
• Breathing problems. Some patients have shortness of breath.
Call your doctor right away if you have trouble breathing.
• Liver problems. Your doctor should do blood tests to check
your liver before you start GILENYA. Call your doctor right away if
you have nausea, vomiting, stomach pain, loss of appetite,
tiredness, dark urine, or if your skin or the whites of your eyes
turn yellow.
• Increases in blood pressure (BP). BP should be monitored
during treatment.
GILENYA may harm your unborn baby. Talk to your doctor if you are
pregnant or planning to become pregnant. Women who can become
pregnant should use effective birth control while on GILENYA, and
for at least 2 months after stopping. If you become pregnant while
taking GILENYA, or within 2 months after stopping, tell your doctor
right away. Women who take GILENYA should not breastfeed, as it is
not known if GILENYA passes into breast milk. A pregnancy registry
is available for women who become pregnant during GILENYA
treatment. Call 1-877-598-7237 or visit
www.gilenyapregnancyregistry.com for more information.
Tell your doctor about all your medical conditions, including if
you had or now have an irregular or abnormal heartbeat; history of
stroke or warning stroke; heart problems; a history of fainting; a
fever or infection, or if you are unable to fight infections; eye
problems; diabetes; breathing or liver problems; or high blood
pressure. Also tell your doctor if you have had chicken pox or have
received the vaccine for chicken pox. Your doctor may do a test for
the chicken pox virus, and you may need to get the vaccine for
chicken pox and wait 1 month before starting GILENYA.
Tell your doctor about all the medicines you take, including
medicines for heart problems or high blood pressure or other
medicines that may lower your heart rate or change your heart
rhythm; medicines that could increase your chance of infections,
such as medicines to treat cancer or control your immune system; or
ketoconazole (an antifungal) by mouth. If taken with GILENYA,
serious side effects may occur. You should not get certain vaccines
while taking GILENYA, and for at least 2 months after
stopping.
The most common side effects with GILENYA were headache, flu,
diarrhea, back pain, abnormal liver tests, and cough.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
For full Prescribing Information and the Medication Guide log onto
www.pharma.us.novartis.com.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as “are being
presented,” “is also presenting,” or similar
expressions, or by express or implied discussions regarding
potential new indications or 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 submitted or approved for any additional
indications or 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 clinical trial results,
including unexpected new clinical data and unexpected additional
analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; 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.
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Novartis Pharmaceuticals Corporation
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Posted: June 2012
