Public HealthFDA Approves Reclast(R) To Prevent Osteoporosis In Postmenopausal Women With Convenient Less Frequent Dosing
Reclast® (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 dose1. Reclast, or Aclasta® 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 osteoporosis1,4.
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 placebo1.
Approximately 22 million women in the US have osteopenia, putting them at increased
risk of osteoporosis, a disease that causes bones to break more easily2,3. Osteoporosis is
a major public health threat affecting an estimated 10 million men and women in the US2.
Although low bone mass is less severe in people with osteopenia than those with
osteoporosis, they are still at increased risk of fractures5. 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 osteopenia6,7,8,9, highlighting the importance of
treating and preventing further bone loss.
"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 fracture4. Additionally, the
Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion
* The tradename is Reclast® in the US and Aclasta® in the rest of the world.
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
women1,5.
"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 baseline1.
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)1. 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 year1.
Reclast significantly increased lumbar spine BMD relative to placebo at the end of the
two-year study1. 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 pReferences
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Pharmaceuticals Corporation; May 2009.
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Mass in Our Nation. Washington, DC: National Osteoporosis Foundation, 2002.
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Limited, 2008.
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Surgeon General. 2004.
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10. Novartis Internal (NPMR), based on Aclasta/Reclast vials sold in the US since launch till Feb 2009.
11. Novartis Health Policy; USMM; Lash Group.
12. Aclasta/ Reclast Ready Report; 2009, Novartis Data on File. Novartis Pharmaceutical Corporation.
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