FDA: Biologics License Application submitted for denosumab

10:05 EDT 31 Jul 2017 | Healio

Agmen recently submitted a supplemental Biologics License Application to the FDA for denosumab for the treatment of people with glucocorticoid-induced osteoporosis, according to a company press release. The application is based on data from a phase 3 study comparing the safety and efficacy of the RANKL inhibitor denosumab (Prolia) with the bisphosphonate risedronate in people receiving glucocorticoid treatment. Study results revealed that denosumab treatment for 12 months led to significantly greater gains in bone mineral density at the lumbar spine and total hip compared with risedronate in adults on sustained glucocorticoid therapy and those newly initiating glucocorticoid therapy. Reported adverse events and serious adverse events were similar between the two groups.

Original Article: FDA: Biologics License Application submitted for denosumab


More From BioPortfolio on "FDA: Biologics License Application submitted for denosumab"

Quick Search

Relevant Topics

The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...

Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...