Biotech Values

[rfj1862]

Biowatch,

As you are probably aware, an intravenous formulation of the bisphosphonate ibandronate is under review by the FDA. I believe it will be administered once yearly. Zolendronic acid, another bisphosphonate, is already approved as a twice-yearly injection for patients with multiple myeloma and certain other disorders. Busy postmenopausal women (those that don't have time for the complicated dosing regimen associated with oral bisphosphonates) are already receiving off-label intermittent IV zolendronic acid.

So denosumab will be entering a crowded intermittent IV dosing marketplace, not to mention that ibandronate is available as a once monthly oral dose.

I see no real advantages here, plus it doesn't have the long term safety and efficacy data that the bisphosphonates have. I bet it's going to be hideously expensive, and probably not reimbursable for a few years.

I'm writing this off the top of my head--without checking facts--so dosing frequency and indications may be a little off.

John