FDA Approves Reclast for Prevention of Fractures

FDA broadens US indication for once-yearly Reclast as only osteoporosis treatment approved for prevention of fractures after a hip fracture

Revised label includes data showing 35% reduction in new clinical fractures in patients treated with Reclast following a recent hip fracture1

Few patients currently receive osteoporosis treatment following hip fracture despite high risk of morbidity and mortality2

Safety and efficacy profile of Reclast, already approved for treatment of postmenopausal osteoporosis1, reinforced in revised label

East Hanover, NJ, June 5, 2008 - The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture1.

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 Reclast3.

"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 fracture2," 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 easily4. Around 10 million people in the US are affected by osteoporosis, which caused an estimated 297,000 hip fractures in the US in 20054. Of those patients who experience a hip fracture, almost a quarter of people over the age of 50 die from complications within one year4.

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 fracture4. Yet, currently few patients are treated for osteoporosis following a hip fracture2.

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 fracture3. Results showed that Reclast increased bone mineral density (BMD) and reduced the risk of new clinical fractures by 35% compared to patients treated with placebo3. 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 group3.

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) 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-spine1. 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 infusion1. 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 disorder5.

The active ingredient in Reclast is zoledronic acid 5mg administered once a year1. Zoledronic acid is also available in a different dosage under the brand name Zometa (zoledronic acid) Injection 4 mg administered every three to four weeks in certain oncologic indications6.

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.

For more information about Reclast, visit www.reclast.com or call 866-RECLAST (866-732-5278).

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such "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 http://www.novartis.com.

References

1. Reclast (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 (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2008.

Posted: June 2008

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Reclast (zoledronic acid) FDA Approval History

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