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.Amgen has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP)of the European Medicines Agency (EMA) for its XGEVA (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumors.
Subscribe to our email newsletter
The CHMP positive opinion is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus Zometa (zoledronic acid) at delaying skeletal-related events (SREs).
In the SRE trials, XGEVA improved in preventing SREs compared to Zometa.
Amgen senior vice president and international chief medical officer Willard Dere said XGEVA offers the ease of every four weeks subcutaneous injection and no requirement for dose adjustment for changes in renal function.
The CHMP also recommended to grant XGEVA an additional year of data and market exclusivity in the EU since the indication was considered significantly new for XGEVA, and based on the clinical benefit of the product in comparison with existing therapies.
Amgen has also submitted marketing applications for XGEVA in Australia, Mexico, Russia and Switzerland.