Novartis osteoporosis drug gets EU nod

The EU approval of Aclasta (zoledronic acid 5mg) follows the August approval of the drug in the US, known there as Reclast.

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

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

The unique once-yearly dosing of this medicine has the potential for significant compliance benefits and improved quality of life for women with osteoporosis."

The company claims the product offers a significant alternative to other oral bisphosphonate which are taken daily, weekly or monthly.

Aclasta, in comparison, is administered as a once-yearly 15-minute intravenous infusion, which surveys have shown is a preferred option for 70 per cent of patients while the one-yearly dosing also provides potential for patient compliance and long-term anti-fracture efficacy.

A study, published in the New England Journal of Medicine in September, showed Aclasta reduced subsequent osteoporotic fractures in hip fracture patients by 35 per cent and mortality by 28 per cent.

Aclasta is now approved in more than 30 countries for the treatment of postmenopausal osteoporosis.

Back in April Reclast was launched in the US as the first treatment in almost a decade for patients with Paget's disease, a metabolic bone disease for which Reclast/Aclasta is already approved in over 60 countries.

Zoledronic acid, the active ingredient in Reclast, is also available in a different dosage under the brand name Zometa, and used in the treatment of bone cancer.

Zometa is a 4mg dosage also administered by 15-minute intravenous infusion, but every three to four weeks rather than once a year.

Last week, the US Food and Drug Administration (FDA) announced they would be reviewing bisphosphonate osteoporosis drugs following a recent publication in The New England Journal of Medicine that raised the question about the association of atrial fibrillation, a heart rhythm disorder.

The review will include Novartis' Reclast and Merck's Fosamax (alendronate).

In Novartis' three-year Pivotal Fracture Trial, involving more than 7,700 women, an increased number of cases of atrial fibrillation were observed in women given Aclasta/Reclast compared to women on a placebo (1.3 per cent versus 0.6 per cent respectively).

The FDA has specifically reviewed Reclast finding that most cases of atrial fibrillation occurred more than a month after drug infusion.

The FDA said it was "unclear" how to interpret the data, but said at this time prescription practices need not be changed.

Meanwhile, the agency is seeking additional data to "allow for an in-depth evaluation of the atrial fibrillation issue for the entire class of bisphosphonates".

The evaluation is expected to take up to 12 months.