Swiss firm Novartis has gained US approval of its once-yearly treatment for postmenopausal osteoporosis, with EU approval expected to follow hot on its heels.
The zoledronic acid therapy, Reclast (Aclasta in the EU), has been given the thumbs up by the US Food and Drug Administration (FDA), making it the first and only once-a-year treatment option for women with postmenopausal osteoporosis.
Reclast will be administered yearly as a 15-minute 5mg intravenous infusion, providing a full year's protection against the effects of osteoporosis in a single sitting. The product offers a significant alternative to other oral bisphosphonate therapies currently available, which have to be taken daily weekly or monthly, says Novartis.
According to the company, clinical data showed that Reclast reduced the risk of spine fractures by 70 per cent and hip fractures by 41 per cent, and also resulted in significantly increased bone mineral density.
Reclast is also the only treatment proven to provide protection against all types of osteoporotic fractures across the key sites of the spine, hip, and non-spinal fractures such as wrist and rib.
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.
Zometa is one of Novartis' top 20 pharmaceutical products, bringing in $636m (€472m) over the first half of 2007, and despite the decline in some European markets Zometa is now the leading infusional bisphosphonate in Japan following its launch just 15 months ago.
Reclast is being touted as a potentially revolutionary treatment option for osteoporosis, being hailed by Novartis as the future "gold standard" in treating the disease, and expected to provide "unsurpassed compliance" in patients.
Novartis was granted a positive opinion from the European Commission's Committee for Medicinal Products for Human Use (CHMP) for Reclast/Aclasta at the end of July (along with additional positive opinions for Exelon (rivastigmine) transdermal patch for the treatment of Alzheimer's disease and Galvus (vildagliptin), a new oral treatment for Type II diabetes).
Novartis expects to hear back for a final decision on EU approval in the next few months, hopefully opening up the EU market for the unique once-yearly product.
The company is also conducting additional studies to examine the use of Reclast/Aclasta to prevent fractures following hip fractures in men and women, treatment of corticosteroid-induced osteoporosis, and male osteoporosis.