Denosumab

Denosumab was first approved as Prolia® by European Medicine Agency (EMA) on May 26, 2010, then approved as Xgeva® and Prolia® by the U.S. Food and Drug Administration (FDA) on June 1, 2010, approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) as Ranmark® on January 18, 2012 and Pralia® on March 25, 2013. It was developed and marketed as Xgeva® and Prolia® by Amgen (also develop and marketed as Ranmark® and Pralia® by Daiichi Sankyo in JP).

Denosumab is a RANK ligand (RANKL) inhibitor, which binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts. It is indicated for the treatment of patients with osteoporosis at high risk for fracture, giant cell tumor of bone, hypercalcemia in malignancy and for the prevention of skeletal-related events in patients with bone metastases from solid tumors. 

Prolia® and Pralia® are available as injection (solution) for subcutaneous use, containing 60 mg/mL of Denosumab in a single-use vial. The recommended dose is 60 mg every 6 monthes.

 Xgeva® and Ranmark® are available as injection (solution) for subcutaneous use, containing 120 mg/1.7 mL of Denosumab in a single-use vial. The recommended dose is 120 mg every 4 weeks.

General Information

Update Date:2016-06-30

Drug Name:
Denosumab
Research Code:
AMG-162
Trade Name:
Prolia® / Xgeva® / Ranmark® / Pralia®
MOA:
RANK ligand inhibitor
Indication:
Solid tumours; Multiple myeloma (MM); Bone cancer; Osteoporosis; Giant cell tumor of bone; Hypercalcemia
Status:
Approved
Company:
Amgen (Originator) , Daiichi Sankyo
Sales:
$2911.8 Million (Y2015);
$2404.4 Million (Y2014);
$1856.5 Million (Y2013);
$1256.1 Million (Y2012);
$554 Million (Y2011);
ATC Code:
M05BX04
Approved Countries or Area

Update Date:2016-06-30

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2014-05-12 New indication Xgeva Hypercalcemia Injection, Solution 120 mg/1.7 mL Amgen Orphan
2013-06-13 New indication Xgeva Giant cell tumor of bone Injection, Solution 120 mg/1.7 mL Amgen Priority/Orphan
2010-06-01 Marketing approval Xgeva Solid tumours Injection, Solution 120 mg/1.7 mL Amgen Priority
2010-06-01 Marketing approval Prolia Osteoporosis Injection, Solution 60 mg/mL Amgen Priority
Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2011-07-13 Marketing approval Xgeva Solid tumours Injection, Solution 120 mg/1.7 mL Amgen
2010-05-26 Marketing approval Prolia Osteoporosis Injection, Solution 60 mg/mL Amgen
Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2013-03-25 Marketing approval Pralia Osteoporosis Injection, Solution 60 mg/mL Daiichi Sankyo, Amgen
2012-01-18 Marketing approval Ranmark Multiple myeloma (MM), Bone cancer Injection, Solution 120 mg/1.7 mL Daiichi Sankyo, Amgen
Biology Structure

Update Date:2015-07-29

Type Whole antibody
Source Human
Molecular Formula C6404H9912N1724O2004S50
Molecular Weight 147532
CAS No. 615258-40-7
Expression System Mammalian Cell