Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Commission (EC) has allowed Amgen to market XGEVA (denosumab) in the Europen Union (EU) as a preventive measure for skeletal-related events (SREs) in adults who are suffering from bone metastases from solid tumors.
Subscribe to our email newsletter
The marketing authorization was granted on the basis of the results of three Phase 3 trials evaluating XGEVA versus zoledronic acid at delaying SREs.
The results of the trial showed clinically meaningful improvement in preventing SREs in comparison to zoledronic acid.
Additionally, the company has also received XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the clinical benefit of XGEVA as compared to existing therapies.