Novartis postmenopausal osteoporosis drug gets CHMP recommendation

Novartis has announced that Aclasta (zoledronic acid 5 mg) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for bone disorder postmenopausal osteoporosis.

The compound is administered as a single dose once a year and has been shown in clinical trial to provide measurable benefits in terms of bone protection, while its simple dosing regimen may boost treatment compliance in the long term.

A study published in the New England Journal of Medicine showed administration of the drug to reduce spine fractures by 70 per cent and hip fractures by 40 per cent when compared to a placebo.

It is expected that the European Commission will follow the CHMP recommendation and grant marketing approval for the compound within three months, with this authorisation to apply to Iceland, Norway and all 27 EU member states.

James Shannon, global head of development at Novartis Pharma, said: “Current oral therapies for osteoporosis have to be taken daily, weekly or monthly and patients often find it difficult to follow these treatment regimens.

“As a result more than 50 per cent of patients are non-compliant with therapy after a year.”

He added that – as a once-yearly treatment – Aclasta can banish concerns regarding compliance while providing “excellent” efficacy for 12 months.

In April 2007, Novartis reported that the results of recently-published clinical trials have suggested that Aclasta could provide a new care standard as a treatment for Paget’s disease of the bone.