FDA Broadens US Indication for Once-yearly Reclast as Only ...

The FDA decision is based on safety and efficacy data from thelandmark Recurrent Fracture Trial, published in The New EnglandJournal of Medicine, showing a significant 35% reduction in therisk of new clinical fractures in patients treated with Reclast3.
"The consequences of osteoporosis can be devastating,particularly hip fractures. However, few patients actually receivetreatment for the prevention of additional fractures after a hipfracture2," said Kenneth G. Saag, MD, MSc, Professor ofMedicine and Epidemiology, Division of Clinical Immunology andRheumatology, University of Alabama at Birmingham. "In thefirst large scale clinical trial of its kind, these data support anefficacious therapeutic option for patients after a hipfracture."
Osteoporosis is a condition in which the bones become weak and canbreak more easily4. Around 10 million people in the US are affectedby osteoporosis, which caused an estimated 297,000 hip fractures inthe US in 20054. Of those patients who experience a hip fracture,almost a quarter of people over the age of 50 die fromcomplications within one year4.
Among those who experience a hip fracture, 85% need help walking atsix months, nearly 20% who could walk before their hip fracturerequire long-term nursing care, and all remain at high risk offurther fracture4. Yet, currently few patients are treated forosteoporosis following a hip fracture2.
The Recurrent Fracture Trial involved more than 2,100 men and womenaged 50 and older with osteoporosis who had experienced a recentlow-trauma hip fracture3. Results showed that Reclast increasedbone mineral density (BMD) and reduced the risk of new clinicalfractures by 35% compared to patients treated with placebo3. Therisk of new spine fractures was reduced by 46%3. The incidence ofall-cause mortality was 9.6% in the Reclast group and 13.3% in theplacebo group3.
The updated US label further reinforces the safety and efficacy ofReclast, the only once-yearly treatment for postmenopausalosteoporosis approved in the US and European Union (EU) (under thename Aclasta®) for the reduction in the incidence of fracturesin all key areas of the body typically affected by this disease,including the hip, spine and non-spine1. Regulatory approval isalso being sought for Aclasta in the EU for this broadenedindication.
Reclast is given as a once-yearly 15-minute intravenous infusion1.This means a single treatment, along with daily calcium and vitaminD supplements, helps protect against fracture for a full year.
"The new label reinforces the potential of Reclast fortreating a range of osteoporosis patients," said TrevorMundel, MD, Head of Global Development Functions at Novartis PharmaAG. "These data support the clear need to treat patients afterhip fracture who are at risk of the potentially devastating andlife-threatening consequences of osteoporosis."
Reclast is already approved in more than 50 countries for thetreatment of postmenopausal osteoporosis and in more than 70countries for the treatment of Paget's disease of bone, the secondmost common metabolic bone disorder5.
The active ingredient in Reclast is zoledronic acid 5mgadministered once a year1. Zoledronic acid is also available in adifferent dosage under the brand name Zometa® (zoledronic acid)Injection 4 mg administered every three to four weeks in certainoncologic indications6.
Patients should not take Reclast if they're on Zometa as itcontains the same ingredient; if they have low blood calcium,kidney problems, or are allergic to Reclast or Zometa; or they'repregnant, plan to become pregnant or nursing.
It's important for patients to drink fluids before getting Reclastto help prevent kidney problems. The most common side effects areflu-like symptoms, fever, muscle or joint pain and headache.Patients should tell their doctor if they have dental problemsbecause rarely, problems with the jaw have been reported withReclast. Patients should tell their doctor if they have low bloodcalcium or cannot take calcium and vitamin D, had surgery involvingthe neck or intestines. In patients with Paget's disease of bone,it is especially important for them to take 1500 mg of calcium and800 IU of vitamin D daily, particularly during the first 2 weeksafter getting Reclast. Patients should discuss all medicinesthey're taking, including prescription and non-prescription,vitamins and herbal supplements. Patients should contact theirdoctor if they develop severe bone, joint or muscle pain, numbness,tingling or muscle spasms.
For more information about Reclast, visit Reclast or call 866-RECLAST (866-732-5278).
Disclaimer
The foregoing release contains forward-looking statements that canbe identified by terminology such "option,""risk," "potential" or similar expressions, orby express or implied discussions regarding potential newindications or labelling for Reclast or regarding potential futurerevenues from Reclast. Such forward-looking statements reflect thecurrent views of the Company regarding future events, and involveknown and unknown risks, uncertainties and other factors that maycause actual results with Reclast to be materially different fromany future results, performance or achievements expressed orimplied by such statements. There can be no guarantee that Reclastwill be approved for any additional indications or labelling in anymarket. Nor can there be any guarantee that Reclast will achieveany 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 orgovernment regulation generally; unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; unexpected regulatory actionsor delays or government regulation generally; the company's abilityto obtain or maintain patent or other proprietary intellectualproperty protection; competition in general; government, industryand general public pricing pressures, and other risks and factorsreferred to in Novartis AG's current Form 20-F on file with the USSecurities and Exchange Commission. Should one or more of theserisks or uncertainties materialize, or should underlyingassumptions prove incorrect, actual results may vary materiallyfrom those anticipated, believed, estimated or expected. Novartisis providing the information in this press release as of this dateand does not undertake any obligation to update any forward-lookingstatements contained in this press release as a result of newinformation, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops,manufactures and markets leading innovative prescription drugs usedto treat a number of diseases and conditions, including those inthe cardiovascular, metabolic, cancer, organ transplantation,central nervous system, dermatological, GI and respiratory areas.The company's mission is to improve people's lives by pioneeringnovel healthcare solutions.
Located in East Hanover, New Jersey, Novartis PharmaceuticalsCorporation is an affiliate of Novartis AG (NYSE: NVS), whichprovides healthcare solutions that address the evolving needs ofpatients and societies. Focused solely on growth areas inhealthcare, Novartis offers a diversified portfolio to best meetthese needs: innovative medicines, cost-saving genericpharmaceuticals, preventive vaccines and diagnostic tools, andconsumer health products. Novartis is the only company with leadingpositions in these areas. In 2007, the Group's continuingoperations (excluding divestments in 2007) achieved net sales ofUSD 38.1 billion and net income of USD 6.5 billion. ApproximatelyUSD 6.4 billion was invested in R&D activities throughout theGroup. Headquartered in Basel, Switzerland, Novartis Groupcompanies employ approximately 98,200 full-time associates andoperate in over 140 countries around the world. For moreinformation, please visit Novartis .
References
1. Reclast® (zoledronic acid) Injection [PrescribingInformation. East Hanover, NJ: Novartis PharmaceuticalsCorporation; June 2008
2. Cadarette SM,, et al. Trends in drug prescribing forosteoporosis after hip fracture, 1995-2004. Journal ofRheumatology. 2007; 35:319-326.
3. Lyles KW, Colon-Emeric CS, Magaziner JS, et al. for the HORIZONRecurrent Fracture Trial. Zoledronic acid and clinical fracturesand mortality after hip fracture. N Engl J Med. 2007:537:1799-1809.
4. National Osteoporosis Foundation. Fast Facts on OsteoporosisBrochure. February 2008.
5. U.S. Department of Health and Human Services. Bone Health andOsteoporosis: A Report of the Surgeon General. 2004, p. 88.
6. Zometa® (zoledronic acid) Injection [PrescribingInformation. East Hanover, NJ: Novartis PharmaceuticalsCorporation. March 2008.
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