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6-Jan-2009

FDA approves once-yearly Reclast® for osteoporosis in men

• Male osteoporosis significantly under-diagnosed and undertreated¹, yet one in four men over 50 will experience an osteoporosis-related fracture²
   
• Reclast increased lumbar spine bone mineral density (BMD) in men with osteoporosis by 6.1% over two years³
   
• Once-yearly Reclast is the only osteoporosis treatment approved to reduce fractures at all key fracture sites, including the hip, spine and other bones³

 

East Hanover, NJ, December 22, 2008 - The US Food and Drug Administration (FDA) has approved once-yearly Reclast® (zoledronic acid) Injection for treatment to increase bone mass in men with osteoporosis.

Although often viewed as a "woman's disease", osteoporosis is also an important male health concern and one in four men older than the age of 50 will experience an osteoporosis-related fracture in his lifetime². If a man experiences a hip fracture - the most serious consequence of osteoporosis - he is twice as likely as a woman to die in the following year because of complications². However, fewer than 3% of men with osteoporosis receive treatment¹.

"Fractures from osteoporosis can have serious debilitating consequences yet this silent epidemic is under-diagnosed and undertreated, especially in men," said Felicia Cosman, MD, professor of Clinical Medicine at Columbia University. "I am encouraged that more patients will now be able to benefit from a full year's treatment with a single annual 15-minute infusion, helping to protect them against osteoporotic fractures."

The FDA approval for osteoporosis in men was based on data from a two-year, double-blind, head-to-head trial in more than 300 osteoporotic men³. The study compared the efficacy and safety of Reclast with a commercially available oral weekly bisphosphonate (active control)³. A total of 153 patients were given a 15-minute Reclast infusion once yearly and 148 patients were given the active control weekly for two years³. The study showed that Reclast increased lumbar spine bone mineral density (BMD) by 6.1% over two years and was non-inferior to the active control³.

Reclast was approved in 2007 for the treatment of postmenopausal osteoporosis and Paget's disease of bone³. And in June 2008, the Reclast treatment of postmenopausal osteoporosis indication was broadened to include the reduction of new clinical fractures in patients after they experienced a recent low trauma hip fracture³.  Reclast is covered by Medicare and most commercial health plans in the US.

Novartis is also pursuing new indications for the prevention of postmenopausal osteoporosis and for the treatment and prevention of glucocorticoid-induced osteoporosis (GIO) in the US.

Since the approval of Reclast, it has been used by more than 164,000 patients in the US. It is the fastest-growing general medicine launched in more than a decade by Novartis Pharmaceuticals Corporation.

Reclast is the only treatment for postmenopausal osteoporosis approved to reduce the risk of fractures at all key sites, including the hip, spine and other bones³.

The active ingredient in Reclast is zoledronic acid 5 mg administered once a year³. 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 indications⁴.

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 if they're pregnant, plan to become pregnant or nursing.

It is 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 or 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 as "will," "likely," "can," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Reclast or regarding potential future revenues from Reclast. You should not place undue reliance on these statements.  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 labeling 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; 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.

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 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 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 97,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References
1. Feldstein A; Elmer PJ; Orwoll E; Herson M; Hillier T. Bone Mineral Density Measurement and Treatment for Osteoporosis in Older Individuals with Fractures: A Gap in Evidence-Based Practice Guideline Implementation. Arch Intern Med 2003; 163:2165-2172.
2. National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure. February 2008.
3. Reclast® (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2008.
4. Zometa® (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.  March 2008.

 

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