Novartis announces European approval of Aclasta

Novartis has announced that Aclasta (zoledronic acid 5 mg) has received approval for use in the European Union as as a once-yearly treatment for women with postmenopausal osteoporosis.

This decision by the European Commission follows recent approval from the US Food and Drug Administration and sees the compound become the first drug to be approved as a treatment to lower the risk of fractures of the hip, spine, wrist, rib and other areas affected by osteoporosis.

Aclasta is administered as a once-yearly intravenous infusion taking 15 minutes – compared to standard oral bisphosphonates treatments that are daily, weekly or monthly – with surveys showing that 70 per cent of patients prefer a yearly administration of the drug to a weekly orally-administered treatment.

James Shannon, global head of development at Novartis Pharma, said: “We are very pleased to receive EU approval, especially as it comes so soon after a similar decision in the US.

“This demonstrates widespread confidence in Aclasta, which provides physicians and patients with a completely new way to manage osteoporosis.”

He added that the once-yearly dosing of the compound could potentially increase quality of life in patients with osteoporosis and boost compliance.

Last month, Novarits reported that osteoporosis patients who have experienced hip fractures exhibited a 35 per cent reduction in the risk of subsequent fractures following administration of Aclasta.