Prevents skeletal-related events. BLA 761444, held by Shanghai Henlius Biotech. Denosumab-Nxxp.
As of Nov 13, 2026, BLA 761444 (Bildyos, Bilprevda), held by Shanghai Henlius Biotech, was first approved by FDA on Oct 29, 2025, with 0 approved supplements and 0 published complete response letters.
Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2, 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2025 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Aug 29, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bildyos60MG/ML · injectable;injection | Denosumab-Nxxp | Rx |
| Bilprevda120MG/1.7ML(70MG/ML) · injectable;injection | Denosumab-Nxxp | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
