Osteoporosis drug Aclasta approved for use in men
pharmafile | October 2, 2008 | News story | Sales and Marketing |Â Â Novartis, aclasta, osteoporosisÂ
Osteoporosis treatment Aclasta has been approved for an extended indication in the European Union.
Novartis’ once-yearly infusion has now been given the green light to treat osteoporosis – a condition more commonly associated with women – in men.
Aclasta (zoledronic acid) was approved in the EU last year for the treatment of osteoporosis in postmenopausal women.
It can now also be prescribed to reduce the risk of new fractures following hip fracture in men and postmenopausal women.
Hip fracture is a potentially life-threatening consequence of osteoporosis, associated with a high risk of morbidity and mortality.
The mortality rate is higher in men than women in the year following the fracture and, over the first six months, men are approximately twice as likely to die as women of a similar age.
“Despite the severity and the large numbers affected, osteoporosis in men has received very little attention,” said Steven Boonen, Professor of Medicine at the Leuven University Centre for Metabolic Bone Diseases in Belgium.
“Most people view osteoporosis solely as a ‘woman’s disease’, but this is not the case,” he added.
It is estimated that one in five men aged over 50 will suffer an osteoporosis-related fracture.
The HORIZON Recurrent Fracture Trial showed a 35% reduction in new fractures in Aclasta-treated patients who recently suffered a low-trauma hip fracture.
There was also a 28% reduction in all-cause mortality and risk of new spine fractures was reduced by 46%.
Novartis says that Aclasta, administered through a drip which takes 15 minutes, bypasses the problem of patients who stop taking their daily, weekly or monthly pills.
The manufacturer’s own trial data showed the drug could reduce the risk of new spine fractures by 70% and the risk of hip fractures by 41% over three years compared to placebo.
There are around 1.6 million hip fractures per year worldwide. In Europe the figure is about 179,000 for men and 711,000 for women.
Other osteoporosis treatments on the market include Roche and GlaxoSmithKline’s monthly drug Bonviva (ibandronic acid), Merck Sharp & Dohme’s Fosamax and Procter & Gamble’s Actonel and Didronel/Didronel PMO.
The new approval for Aclasta covers all 27 EU states plus Norway and Iceland.
Novartis has also applied for US approval to treatment osteoporosis in men, where the brand is known as Reclast and was last year approved for Paget’s disease.
Related Content
Novartis receives SMC approval for early breast cancer treatment
Novartis has announced that its treatment for early breast cancer, Kisqali (ribociclib), has received approval …
Novartis candidate for Sjögren’s disease presents positive results
Novartis has reported positive results from two phase 3 clinical trials – NEPTUNUS-1 and NEPTUNUS-2 …
First malaria medicine for infants under 4.5kg receives approval
Coartem (artemether-lumefantrine) Baby, or Riamet, has been approved by Swissmedic as the first malaria medicine …
