Dr Reddys gets CDSCO Committee recommendation for approval for additional indications of Desosumab
Recently, the Hyderabad-based Dr Reddy's Labs presented its proposal before the CDSCO Committee for an additional indication for Denosumab 120 mg/1.7ml (70 mg/ml) solution for injection and received a recommendation for approval of additional indications of the drug.
New Delhi: Drug major, Dr Reddy's Laboratories (Dr Reddys) recently received a recommendation from the Subject Experts Committee of Central Drug Standard Control Organisation(CDSCO) for approval of additional indications for Desosumab 70mg/mL (Xgeva).
Xgeva is a Rank ligand (RANKL) inhibitor and is approved in India for the prevention of skeletal-related events in patients with advanced malignancies involving bone. The Xgeva brand of denosumab is used to prevent bone fractures and other skeletal conditions in people with multiple myeloma, and in people with tumours that have spread to the bone. Xgeva is also used to treat high blood levels of calcium caused by cancer.
In 2016, Dr Reddy's had expanded its strategic collaboration with the US-based independent biotechnology firm Amgen to market and distribute in India three of latter's medicines, used in the therapy areas of oncology and osteoporosis. Under the terms of collaboration, Dr Reddy's was responsible for commercialising Xgeva (denosumab).
Recently, the Hyderabad-based drugmaker presented its proposal before the CDSCO Committee for an additional indication for Denosumab 120 mg/1.7ml (70 mg/ml) solution for injection.
After detailed deliberation, the CDSCO committee recommended for approval of the following indications:
- Prevention of skeletal-related events in patients with multiple myeloma.
- Treatment of giant cell tumour of bone in adults or skeletally mature adolescents
CDSCO is the nodal regulatory head within which the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare.