2006-08-17

Osteoporosis Treatment Now Approved in Europe & US for Men


Paris, France (ots/PRNewswire) -

- Male Osteoporosis: Neglected and Under Treated

PARIS, France, August 17 /PRNewswire/ --

The US Food and Drug Administration (FDA) this week approvedActonel(R) 35mg (risedronate sodium tablets) for 'treatment toincrease bone mass in men with osteoporosis'. This follows thepositive outcome in July 2006 of the European application for theadditional indication of 'treatment of osteoporosis in men at highrisk of fracture.' National approvals will now follow in alltwenty-five EU member states. This new indication now opens the doorfor more men with osteoporosis to benefit from Actonel treatment.

'Male osteoporosis is neglected and under-treated,' said PierreDelmas, Professor of Medicine and Rheumatology at the UniversitéClaude Bernard, in Lyon, France. 'We have to ask ourselves why otherconditions such as prostate cancer receive more attention thanosteoporosis, when in reality men over 50 are at far greater risk ofosteoporosis than they are of prostate cancer. We cannot accept thelow levels of awareness that exist among patients and physiciansbecause osteoporosis is such a devastating and debilitating diseasefor men.'

Approximately half of male osteoporosis cases are associated withaging. Men with age-related osteoporosis usually develop the diseaselater in life than do women. With an aging population and increasinglife expectancy, age-related cases of male osteoporosis are expectedto increase. The other half of all male osteoporosis cases are due tosecondary causes such as oral steroid use, low testosterone(hypogonadism), and heavy alcohol use (1).

The approval of Actonel for men with osteoporosis is based on atwo-year, placebo-controlled, double-blind multi-centre clinicaltrial of 284 male patients with osteoporosis (2). In the trial,patients treated with once-a-week Actonel 35mg experiencedstatistically significant improvements in lumbar spine bone mineraldensity at all time points measured, 6, 12 and 24 months. Likewise,statistically significant reductions in bone turnover markers wereachieved at all time points measured, 3, 6, 12 and 24 months.Actonel was well-tolerated and adverse events were generally similarbetween patients receiving Actonel and patients receiving placebo.The most commonly reported adverse events were constipation, backpain, arthralgia, influenza and nasopharyngitis.

'This approval builds upon the efficacy of Actonel seen in women,'said David Cahall, International Medical Director, sanofi-aventis.'With this new indication we hope many men, a group of patients thatare often overlooked, will now be able to benefit from treatment withActonel'.

About Actonel(R) (risedronate sodium tablets)

In Europe, Actonel 5 mg daily and 35 mg once-a-week are indicatedfor the treatment of postmenopausal osteoporosis to reduce the riskof vertebral fractures and the treatment of establishedpostmenopausal osteoporosis to reduce the risk of hip fractures.Actonel 5mg daily is indicated for the prevention of osteoporosis inpostmenopausal women with increased risk of osteoporosis and tomaintain or increase bone mass in post menopausal women undergoinglong-term (more than 3 months) systemic corticosteroid treatment atdoses greater than or equal to 7.5mg/day prednisone or equivalent.Actonel 35mg is indicated for the treatment of osteoporosis in men athigh risk of fractures. The 5 mg dose is not approved for malesreceiving systemic corticosteroid treatment and is not approved formale osteoporosis. The 35 mg dose is not approved in men or womenreceiving long-term systemic corticosteroids and is not approved forthe prevention of osteoporosis in postmenopausal women. Please seethe Summary of Product Characteristics for Actonel(R) 5mg and 35mg(risedronate sodium tablets) for more information.

In the USA, Actonel 5 mg daily and 35 mg once-a-week are indicatedfor the prevention and treatment of postmenopausal osteoporosis inwomen. Actonel 35 mg once-a-week is indicated to increase bone massin men with osteoporosis. Actonel 5mg daily is indicated for theprevention and treatment of glucocorticoid-induced osteoporosis inmen and women who are either initiating or continuing systemicglucocorticoid treatment (greater than or equal to 7.5 mg/dprednisone or equivalent) for chronic diseases. Please see fullprescribing information for Actonel(R) (risedronate sodium tablets)for more information. For a copy of the full prescribing informationfor Actonel visit the Actonel website at www.actonel.com.

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed in May 1997 topromote bone health and disease awareness through numerous activitiesto support physicians and patients around the globe. It is acollaboration between Procter & Gamble Pharmaceuticals andsanofi-aventis U.S.

About Procter & Gamble (NYSE:PG)

Three billion times a day, P&G brands touch the lives of peoplearound the world. The company has one of the strongest portfolios oftrusted, quality, leadership brands, including Pampers(R), Tide(R),Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R). Bounty(R),Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R),Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head& Shoulders(R), Wella, Gillette(R), and Braun. The P&G communityconsists of almost 140,000 employees working in over 80 countriesworldwide. Please visit http://www.pg.com for the latest news andin-depth information about P&G and its brands.

About sanofi-aventis

Sanofi-aventis is the world's third largest pharmaceuticalcompany, ranking number one in Europe. Backed by a world-class R&Dorganization, sanofi-aventis is developing leading positions in sevenmajor therapeutic areas: cardiovascular, thrombosis, oncology,metabolic diseases, central nervous system, internal medicine, andvaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and inNew York (NYSE: SNY)

For P&G: All statements, other than statements of historical factincluded in this release, are forward-looking statements, as thatterm is defined in the Private Securities Litigation Reform Act of1995. In addition to the risks and uncertainties noted in thisrelease, there are certain factors that could cause actual results todiffer materially from those anticipated by some of the statementsmade. These include: (1) the ability to achieve business plans,including with respect to lower income consumers and growing existingsales and volume profitably despite high levels of competitiveactivity, especially with respect to the product categories andgeographical markets (including developing markets) in which thecompany has chosen to focus; (2) successfully executing, managing andintegrating key acquisitions (including the Domination and ProfitTransfer Agreement with Wella); (3) the ability to manage andmaintain key customer relationships; (4) the ability to maintain keymanufacturing and supply sources (including sole supplier and plantmanufacturing sources); (5) the ability to successfully manageregulatory, tax and legal matters (including product liabilitymatters), and to resolve pending matters within current estimates; 6)the ability to successfully implement, achieve and sustain costimprovement plans in manufacturing and overhead areas, including thesuccess of the company's outsourcing projects; (7) the ability tosuccessfully manage currency (including currency issues in volatilecountries), interest rate and certain commodity cost exposures; (8)the ability to manage the continued global political and/or economicuncertainty and disruptions, especially in the company's significantgeographical markets, as well as any political and/or economicuncertainty and disruptions due to terrorist activities; (9) theability to successfully manage increases in the prices of rawmaterials used to make the company's products; (10) the ability tostay close to consumers in an era of increased media fragmentation;and (11) the ability to stay on the leading edge of innovation. Foradditional information concerning factors that could cause actualresults to materially differ from those projected herein, pleaserefer to our most recent 10-K, 10-Q and 8-K reports

References

1) Kamel HK. Male Osteoporosis: New trends in diagnosis and therapy. Drugs Aging 2005; 22 (9): 741-748 2) Boonen S et al. Oral Risedronate Treatment in Men with Osteoporosis: Study Design and Baseline Characteristics. Poster presented at ASBMR 2005 (number SU404)

ots Originaltext: The Alliance for Better Bone HealthIm Internet recherchierbar: http://www.presseportal.de

Contact:Salah Mahyaoui, sanofi-aventis, Tel: +33(0)153-774-031, Email: Salah.mahyaoui@sanofi-aventis.com

The Alliance for Better Bone Health

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