The US Food and Drug
Administration (FDA) has broadened the US indication for once-yearly
Reclast(R) (zoledronic acid) Injection to include the prevention of new
clinical fractures in patients who have recently had a low-trauma hip
fracture(1).
No other osteoporosis treatment has demonstrated a reduction of new
clinical fractures in patients who have recently had a low-trauma hip
fracture (e.g., due to a fall from standing height or less)(1). A clinical
fracture is defined as a composite endpoint of skeletal sites excluding
finger, face and toe.
The FDA decision is based on safety and efficacy data from the landmark
Recurrent Fracture Trial, published in The New England Journal of Medicine,
showing a significant 35% reduction in the risk of new clinical fractures
in patients treated with Reclast(3).
"The consequences of osteoporosis can be devastating, particularly hip
fractures. However, few patients actually receive treatment for the
prevention of additional fractures after a hip fracture(2)," said Kenneth
G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of
Clinical Immunology and Rheumatology, University of Alabama at Birmingham.
"In the first large scale clinical trial of its kind, these data support an
efficacious therapeutic option for patients after a hip fracture."
Osteoporosis is a condition in which the bones become weak and can
break more easily(4). Around 10 million people in the US are affected by
osteoporosis, which caused an estimated 297,000 hip fractures in the US in
2005(4). Of those patients who experience a hip fracture, almost a quarter
of people over the age of 50 die from complications within one year(4).
Among those who experience a hip fracture, 85% need help walking at six
months, nearly 20% who could walk before their hip fracture require
long-term nursing care, and all remain at high risk of further fracture(4).
Yet, currently few patients are treated for osteoporosis following a hip
fracture(2).
The Recurrent Fracture Trial involved more than 2,100 men and women
aged 50 and older with osteoporosis who had experienced a recent low-trauma
hip fracture(3). Results showed that Reclast increased bone mineral density
(BMD) and reduced the risk of new clinical fractures by 35% compared to
patients treated with placebo(3). The risk of new spine fractures was
reduced by 46%(3). The incidence of all-cause mortality was 9.6% in the
Reclast group and 13.3% in the placebo group(3).
The updated US label further reinforces the safety and efficacy of
Reclast, the only once-yearly treatment for postmenopausal osteoporosis
approved in the US and European Union (EU) (under the name Aclasta(R)) for
the reduction in the incidence of fractures in all key areas of the body
typically affected by this disease, including the hip, spine and
non-spine(1). Regulatory approval is also being sought for Aclasta in the
EU for this broadened indication.
Reclast is given as a once-yearly 15-minute intravenous infusion(1).
This means a single treatment, along with daily calcium and vitamin D
supplements, helps protect against fracture for a full year.
"The new label reinforces the potential of Reclast for treating a range
of osteoporosis patients," said Trevor Mundel, MD, Head of Global
Development Functions at Novartis Pharma AG. "These data support the clear
need to treat patients after hip fracture who are at risk of the
potentially devastating and life-threatening consequences of osteoporosis."
Reclast is already approved in more than 50 countries for the treatment
of postmenopausal osteoporosis and in more than 70 countries for the
treatment of Paget's disease of bone, the second most common metabolic bone
disorder(5).
The active ingredient in Reclast is zoledronic acid 5 mg administered
once a year(1). Zoledronic acid is also available in a different dosage
under the brand name Zometa(R) (zoledronic acid) Injection 4 mg
administered every three to four weeks in certain oncologic indications(6).
Patients should not take Reclast if they're on Zometa as it contains
the same ingredient; if they have low blood calcium, kidney problems, or
are allergic to Reclast or Zometa; or they're pregnant, plan to become
pregnant or nursing.
It's important for patients to drink fluids before getting Reclast to
help prevent kidney problems. The most common side effects are flu-like
symptoms, fever, muscle or joint pain and headache. Patients should tell
their doctor if they have dental problems because rarely, problems with the
jaw have been reported with Reclast. Patients should tell their doctor if
they have low blood calcium or cannot take calcium and vitamin D, had
surgery involving the neck or intestines. In patients with Paget's disease
of bone, it is especially important for them to take 1500 mg of calcium and
800 IU of vitamin D daily, particularly during the first 2 weeks after
getting Reclast. Patients should discuss all medicines they're taking,
including prescription and non-prescription, vitamins and herbal
supplements. Patients should contact their doctor if they develop severe
bone, joint or muscle pain, numbness, tingling or muscle spasms.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "option," "risk," "potential" or similar
expressions, or by express or implied discussions regarding potential new
indications or labelling for Reclast or regarding potential future revenues
from Reclast. Such forward-looking statements reflect the current views of
the Company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Reclast
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Reclast will be approved for any additional indications or
labelling in any market. Nor can there be any guarantee that Reclast will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding 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; unexpected regulatory actions or delays or government
regulation generally; 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, 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 Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides
healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic
tools, and consumer health products. Novartis is the only company with
leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion
was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 98,200
full-time associates and operate in over 140 countries around the world.
For more information, please visit novartis.
References
1. Reclast(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2008
2. Cadarette SM, et al. Trends in drug prescribing for osteoporosis
after hip fracture, 1995-2004. Journal of Rheumatology. 2007;
35:319-326.
3. Lyles KW, Colon-Emeric CS, Magaziner JS, et al. for the HORIZON
Recurrent Fracture Trial. Zoledronic acid and clinical fractures and
mortality after hip fracture. N Engl J Med. 2007:537:1799-1809.
4. National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure.
February 2008.
5. U.S. Department of Health and Human Services. Bone Health and
Osteoporosis: A Report of the Surgeon General. 2004, p. 88.
6. Zometa(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2008.
Novartis
novartis
View drug information on Reclast; Zometa.
Комментариев нет:
Отправить комментарий