Kefdensis (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Stada Arzneimittel AG
- Status
- Authorised
- Therapeutic area
- Bone Resorption; Osteoporosis; Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Mon 17 Nov 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006490
- ATC
- M05BX04
- Official record
- www.ema.europa.eu
Indication
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Kefdensis significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Regulatory milestones
Kefdensis (denosumab) approved in the EU
Marketing authorisation to Stada Arzneimittel AG; Biosimilar, Additional monitoring · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.