Novartis gets extra EU authorization for Aclasta

Swiss drug major Novartis has received an extended European Marketing Authorization for its Aclasta (zoledronic acid) 5mg once-yearly infusion for the prevention of fractures in patients with osteoporosis. Known as Reclast in the USA, the therapy is now also indicated for use in men at risk of fractures, as well as women. The firm notes that, whilst male osteoperosis fragility fractures are less common, they are associated with a higher risk of morbidity and death than for women. The label for the product has also been expanded to include new data .