FDA approves ReclastÂ® to prevent osteoporosis in postmenopausal women
with convenient less frequent dosing
FDA approves ReclastÂ® to prevent osteoporosis in postmenopausal women
with convenient less frequent dosing
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* Single infusion of Reclast increases bone mass for two years in
postmenopausal women with osteopenia, a condition that can lead
* Approximately 22 million women in US have osteopenia, or low bone
mass, putting them at increased risk of fractures of hip, spine
* Reclast already approved as once-yearly infusion in US and EU
(under trade-name Aclasta), for the treatment of postmenopausal
Basel, June 1, 2009 - ReclastÂ® (zoledronic acid 5 mg) Injection[*]
has been approved by the US Food and Drug Administration (FDA) as the
first and only therapy to prevent postmenopausal osteoporosis for two
years with a single dose. Reclast, or AclastaÂ® as it is known
outside the US, is already approved in more than 80 countries
including the US and EU as a once-yearly infusion for the treatment
of postmenopausal osteoporosis,.
The FDA decision is based on a study involving more than 500
postmenopausal women with osteopenia, or low bone mass, showing that
a single infusion of Reclast significantly increased bone mineral
density (BMD) at two years compared to placebo.
Approximately 22 million women in the US have osteopenia, putting
them at increased risk of osteoporosis, a disease that causes bones
to break more easily,. Osteoporosis is a major public health
threat affecting an estimated 10 million men and women in the US.
Although low bone mass is less severe in people with osteopenia than
those with osteoporosis, they are still at increased risk of
fractures. In fact, research shows that approximately half of
women who experience a fragility fracture, or a broken bone due to a
fall from standing height or less, have osteopenia,,,,
highlighting the importance of treating and preventing further bone
"It is very important to treat postmenopausal women with low bone
mass to prevent them from progressing to osteoporosis," said Mone
Zaidi, MD, PhD, Professor of Medicine, Geriatrics, and Physiology and
Director of The Mount Sinai Bone Program at Mount Sinai School of
Medicine in New York, USA. "The dosing of Reclast for the prevention
of postmenopausal osteoporosis offers an advance over existing
therapies since it can be given once every two years, instead of
daily, weekly or monthly."
Reclast is already approved in the US as a once-yearly infusion to
treat postmenopausal osteoporosis, to increase bone mass in men with
osteoporosis, and to treat and prevent osteoporosis caused by
glucocorticoids, commonly know as steroids. In the EU, Aclasta is
approved for the treatment of osteoporosis in postmenopausal women
and in men at increased risk of fracture, including those with a low
trauma hip fracture. Additionally, the Committee for Medicinal
Products for Human Use (CHMP) has issued a positive opinion
recommending Aclasta for the treatment of glucocorticoid-induced
osteoporosis in the EU. Aclasta/Reclast is also approved in the US
and EU for the treatment of Paget's disease of bone, the second most
common metabolic bone disorder, in men and women,.
"We are very pleased with this latest US approval that recognizes the
large body of safety and efficacy data for Aclasta/Reclast and
underlines its potential to protect patients with a number of bone
disorders," said Trevor Mundel, MD, Global Head of Development at
Novartis Pharma AG. "Women with low bone mass in the US now have an
important new option that is proven to strengthen their bones, and
therefore prevent the onset of osteoporosis, for a full two years
with only one infusion."
The new US indication to prevent bone loss in postmenopausal women
with osteopenia was based on a two-year randomized, multi-center,
double-blind, placebo-controlled study of 581 postmenopausal women
older than 45 years of age. The primary endpoint was the change in
BMD at two years relative to baseline.
This study included women in early menopause (i.e. within five years
of menopause) and late menopause (i.e. more than five years from
menopause). Patients were divided into three groups and received
either Reclast at the beginning of the study and again at one year,
Reclast at the beginning of the study and placebo at one year, or
placebo at the beginning of the study and placebo again at one
Reclast significantly increased lumbar spine BMD relative to placebo
at the end of the two-year study. Treatment with Reclast given as
a single dose at the beginning of the study increased lumbar spine
BMD by 6.3% in the early menopause group and by 5.4% in the late
menopause group at two years (both p<0.0001).
Aclasta/Reclast is generally safe and well tolerated. The most common
adverse events associated with Aclasta/Reclast are transient
post-dose symptoms such as fever and muscle pain. Most of these
symptoms occur within the first three days following Aclasta/Reclast
administration and resolve within three days. The incidence of such
post-dose symptoms can be reduced with the administration of
paracetamol or ibuprofen shortly after Aclasta/Reclast infusion.
Aclasta/Reclast has been used in nearly 500,000 patients worldwide,
including more than 238,000 in the US, to help prevent fractures.
It is available in all 50 US states and reimbursed by all Medicare
Part B carriers and virtually all health insurance plans. Reclast
can be administered in physicians' offices or at one of the more than
5,600 infusion centers located throughout the US.
Zoledronic acid, the active ingredient in Aclasta/Reclast, is also
available under the trade-name ZometaÂ® for use in oncology
The foregoing release contains forward-looking statements that can be
identified by terminology such as "risk," "recommending,"
"potential," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling for
Aclasta/Reclast or regarding potential future revenues from
Aclasta/Reclast. 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 Aclasta/Reclast to be materially different from any
future results, performance or achievements expressed or implied by
such statements. There can be no guarantee that Aclasta/Reclast will
be approved for any additional indications or labeling in any market.
Nor can there be any guarantee that Aclasta/Reclast will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding Aclasta/Reclast 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.
Novartis AG 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 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
 ReclastÂ® (zoledronic acid) Injection [Prescribing Information].
East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2009.
 National Osteoporosis Foundation. Fast Facts on Osteoporosis
Brochure. February 2008.
 National Osteoporosis Foundation. America's Bone Health: The
State of Osteoporosis and Low Bone Mass in Our Nation. Washington,
DC: National Osteoporosis Foundation, 2002.
 Aclasta Summary of Product Characteristics. West Sussex, United
Kingdom: Novartis Europharm Limited, 2008.
 U.S. Department of Health and Human Services. Bone Health and
Osteoporosis: A Report of the Surgeon General. 2004.
 Siris ES, et al. Bone Mineral Density Thresholds for
Pharmacological Intervention to Prevent Fractures. Arch Intern Med.
 Siris ES, Miler PD, Barrette-Connor E, et al. Identification and
fracture outcomes of undiagnosed low bone mineral density in
postmenopausal women JAMA. 2001; 286:2815-2822.
 Wainwright SA, Marshall LM, Ensrud KE, et al. Hip fracture in
women without osteoporosis. JCEM. 2005; 90:2787-2793.
 Schuit SCE, van der Klift M, Weel AEAM, et al. Fracture incidence
and association with bone mineral density in elderly men and women:
the Rotterdam Study. Bone. 2004; 34:195-202.
 Novartis Internal (NPMR), based on Aclasta/Reclast vials sold in
the US since launch till Feb 2009.
 Novartis Health Policy; USMM; Lash Group.
 Aclasta/ Reclast Ready Report; 2009, Novartis Data on File.
Novartis Pharmaceutical Corporation.
[*] The tradename is ReclastÂ® in the US and AclastaÂ® in the rest of
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