Romosozumab drug research has been submitted to the FDA for testing
A new osteoporosis treatment, called romosozumab, has been accepted for review as of September 26, 2016, by the U.S. Food and Drug Administration. The FDA will review the Biologics Licence Application (BLA) to determine the effectiveness of the new drug.
Romosozumab, though not yet approved for the treatment of osteoporosis, is designed to inhibit bone breakdown, while also increasing bone formation. In a global Phase 3 program known as FRAME (FRActure study in postmenopausal woMen with ostEoporosis), romosozumab was tested for its ability to inhibit a naturally occurring protein in the bone, sclerostin, which could decrease the possibility of fractures in postmenopausal women.
Developed by the global pharmaceutical organizations Amgen and UCB, the BLA was submitted on July 19, 2016, for approval based on the FRAME study. The FDA has set a target action date for romosozumab for July 19, 2017.
The Mission of Amgen and UCB
Amgen, with locations worldwide, is a biotechnology organization that seeks to find innovative therapeutics for individuals that are suffering from serious illnesses. They specifically focus on unmet or underfunded medical needs, using advanced human genetics to seek out answers about complex diseases. Since 1980, Amgen has been a pioneer in the world of independent biotechnology companies, with a mission to change the lives of individuals facing chronic or seemingly incurable ailments.
UCB, located in Brussels, Belgium, also works to develop innovative treatments for those facing diseases of the immune or central nervous system. Their mission is to improve quality of life through understanding the clinical, economic, social and personal needs of their patients, and working with physicians and clinicians to achieve this higher quality of life. They seek to understand the “real life experience of patients so that ultimately our teams are able to deliver the right drug and the right care to the right patient” (ucb.com).
Together, Amgen and UCB have developed the experimental drug, romosozumab, as a new osteoporosis treatment in postmenopausal women.
If the drug is shown to be effective, it could have a major impact on the treatment of postmenopausal women. This new osteoporosis treatment could make strides in improving quality of life and supporting life in motion for those living with osteoporosis.