Products

Date: 2011-12-20

Type of information: Granting of a Market Authorisation in the EU

Product name: Xgeva®

Compound: denosumab

Therapeutic area: Cancer - Oncology

Action mechanism:

• monoclonal antibody. Xgeva® is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). Xgeva® prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.

Company: Amgen (USA)

Disease: prevention of skeletal-related events in adults with bone metastases from solid tumour

Latest news: • On May 20, 2011, the CHMP has adopted a positive opinion recommending the granting of marketing autorisation for Xgeva® (denosumab), from Amgen, intended for the prevention of skeletal-related events in adults with bone metastases from solid tumours.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE: 2010-06-04

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2011-07-26

Favourable opinion UE: 2011-05-20

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes