Further Recent Biologics Applications

EMA News  •  U.S. FDA News

We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals.

Amgen announced today both the submission of a supplemental BLA to the FDA and an application for a variation to the marketing authorization to the EMA for XGEVA (denosumab).  With these applications, Amgen seeks to expand XGEVA’s indication to include patients with multiple myeloma.  XGEVA is currently indicated for prevention of skeletal-related events in patients with bone metastases from solid tumors.

Amgen and UCB reported last week on the results of a phase 2 study of EVENITY (romosuzumab), an investigational new therapy for osteoporosis.  Amgen and UCB reported that patients who initially received  EVENITY followed by placebo and then a second course of EVENITY showed significant increases in bone mineral density (BMD) to an extent similar to the initial EVENITY treatment, and that patients who received a second course of EVENITY after denosumab further experienced increased BMD at the lumbar spine, while maintaining BMD at the total hip and femoral neck.

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