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Reclast Receives US Approval As A Highly Effective Treatment For Patients With Paget's
Disease Of The Bone
Reclast (zoledronic acid) has received US regulatory approval as the first new treatment in nearly a
decade for patients with a bone condition known as Paget's disease, estimated to affect about one
million people in the US alone.
Reclast, which is marketed as Aclasta in other countries, is the first approved treatment for Paget's
disease patients to be given as a single-dose infusion compared to current oral therapies that must to
be taken daily for up to six months. This medicine was first launched in Germany in May 2005 for
Paget's disease and is now approved in more than 50 countries.
Paget's disease is a chronic, long-lasting and often painful bone disorder that causes abnormal bone
growth due to a malfunction in the body's regular bone-building process. An outcome can be weak
and brittle bones, causing them to break more easily. Approximately four million people worldwide
have the condition.
"The fact that Reclast is both highly effective and can last for several years in most patients could
make this the new standard of care for Paget's patients," said Frederick R. Singer, MD, Director of the
Endocrine/Bone Disease Program at John Wayne Cancer Institute in Santa Monica, California.
"Current bisphosphonate therapy, while generally effective, does not induce similar long-term
Clinical studies show Aclasta/Reclast is more effective, starts working faster and offers a longer
period of remission than Actonel (risedronate sodium)*, the current treatment standard for patients with
Paget's disease. Aclasta/Reclast is administered as a single 5 mg, 15-minute intravenous infusion by a
"We believe Aclasta/Reclast provides a critical new treatment option for people who suffer from
Paget's disease," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
"Furthermore, we are exploring the full clinical potential of this agent in treating other metabolic bone
diseases, including postmenopausal osteoporosis."
The approval by the US Food and Drug Administration (FDA) was based on efficacy and safety data
comparing a single dose of Aclasta/Reclast with Actonel (30 mg risedronate) taken daily for 60 days in
two identically designed six month trials. Results combined from both trials showed 96 percent of
patients taking Aclasta/Reclast responded to treatment compared to 74 percent of patients taking
Actonel at six months. Results of these head-to-head studies were published in the September 1, 2005
issue of the New England Journal of Medicine.
These studies also demonstrated that Aclasta/Reclast starts working faster, showing a significant
difference as early as two months. Patients who took Aclasta/Reclast responded to treatment after an
average of 64 days versus 89 days for those taking Actonel. Overall, the number of patients with
adverse events was similar in the Aclasta/Reclast and Actonel groups. About Paget's disease
In Paget's disease, the normal cycle of new bone replacing broken-down bone is disrupted: too much
bone breaks down and the replacement bone is structurally weak. Patients may experience bone pain,
skeletal deformity, pathological fractures, secondary arthritis, neurological complications and deafness
that can impede their ability to perform routine activities such as walking and prolonged standing.
Paget's disease can be difficult to diagnose and may often be left untreated as not all patients
experience noticeable symptoms.
"Paget's disease is a serious and commonly overlooked condition that can be very debilitating for
some patients," said Charlene Waldman, executive director, The Paget Foundation. "This approval is
an important milestone for people with Paget's disease because it has been more than nine years
since a new treatment option has been made available." About Aclasta/Reclast
HORIZON, the ongoing clinical program of Aclasta/Reclast, is one of the most comprehensive drug
evaluation programs ever undertaken in the area of metabolic bone diseases. Approximately 13,000
patients worldwide have participated in the program in more than 400 centers. It is the first program to
study a once-yearly dosing regimen for the prevention and treatment of postmenopausal osteoporosis.
Other studies involved in the program include prevention of fractures following a hip fracture in men
and women, and treatment of corticosteroid-induced osteoporosis and male osteoporosis.
The European Medicines Agency (EMEA) and FDA are currently reviewing submissions for the
approval of Aclasta/Reclast as a once-yearly treatment for postmenopausal osteoporosis. Zoledronic
acid, the active ingredient of Aclasta/Reclast, is also available under the brand name Zometa for use in
The US regulatory approval of Reclast in treating patients with Paget's disease comes after Novartis
supplied responses to "approvable letters", which are issued when the FDA is prepared to approve an
investigational medicine and contain conditions that must be met prior to final US approval. Disclaimer
The foregoing press release contains forward-looking statements that can be identified by the use of
forward-looking terminology such as "estimated", "could", "potential", "can", "may", or by express or
implied discussions regarding potential future regulatory approvals of Reclast/Aclasta for additional
indications, or potential future sales of Reclast/Aclasta. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Reclast/Aclasta will be approved for any additional
indications in any market, or that Reclast/Aclasta reach any particular level of sales. In particular,
management's expectations regarding Reclast/Aclasta could be affected by, among other things,
unexpected regulatory actions or delays in government regulation generally; unexpected clinical trial
results, including additional analysis of existing clinical data, and new clinical data; competition in
general; government, industry, and general public pricing pressures; the company's ability to obtain or
maintain patent or other proprietary intellectual property protection; as well as the additional factors
discussed in Novartis AG's Form 20-F filed 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 described herein as anticipated, believed,
estimated or expected. Novartis is providing this information as of this date and does not undertake
any obligation to update any forward-looking statements contained in this document as a result of new
information, future events or otherwise. About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and
improve well-being. Our goal is to discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based
portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-
quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is
the only company with leadership positions in these areas. In 2006, the Group's businesses achieved
net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was
invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 101,000 associates and operate in over 140 countries around the world. For more
information, please visit http://www.novartis.com. References
1. U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the
Surgeon General. 2004:68
2. Ankrom MA, Shapiro JR. Paget's disease of bone (osteitis deformans). J Am Geriatr Soc
3. Mattson Jack (EPI database).
4. Lyles K, Hosking D, Miller P et al. Zoledronic Acid Produces Greater and Faster Efficacy Versus
Risedronate in Patients with Paget's Disease. Osteoporos Int 2005: 16(3); S1-S15.
5. Miller P, Brown J, Hosking D et al. Zoledronic Acid Produces Higher and More Rapid Therapeutic
Response Rates versus Risedronate in Patients with Paget's Disease. HORIZON TOP Trial Results.
Data on file.
6. Reid IR, Miller P, Lyles K et al. A single infusion of zoledronic acid improves remission rates in Paget's disease: a randomized controlled comparison with risedronate. N Engl J Med 2005; 353: 898-908. 7. Hosking D, Meunier P, Ringe J et al. Paget's disease of bone: diagnosis and management. BMJ 1996;312:491-494.
Article URL: http://www.medicalnewstoday.com/articles/68619.php
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