BioCentury's websites will be down for upgrades starting at 11 p.m. PDT on Monday, August 26. We expect the downtime to last no more than 6 hours, and we apologize for any inconvenience.

12:00 AM
 | 
Aug 04, 2008
 |  BioCentury  |  Product Development

Denosumab's competitive profile

With most of the data now in, Amgen Inc. has steadily built evidence that its denosumab is working in osteoporosis. Assuming no surprises emerge from full disclosure of its FREEDOM trial next month, attention will turn to the opportunity for the company to carve out a substantial market niche for the antibody, based on the agent’s infrequent dosing regimen and the tolerability problems associated with marketed oral bisphosphonates.

Denosumab is a human mAb targeting receptor activator of NF-kappa B ligand (RANKL) that works by blocking bone resorption. Since the beginning of June, the company has been disclosing Phase III data showing the drug has consistently reversed bone loss in clinical trials in patients with osteoporosis or bone-metastatic cancers (see BioCentury, June 2 & July 21).

The most recent data, revealed July 25, showed that a twice-yearly dosing regimen significantly reduced the risk of fractures vs.placebo in 7,800 postmenopausal women with osteoporosis after three years in the Phase III FREEDOM trial (see BioCentury, July 28).

The company has not said...

Read the full 841 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >