Lupin Gets CDSCO Panel Nod To study osteoporosis drug Denosumab
New Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of Denosumab with Prolia indicated for the management of osteoporosis.
However, this approval is subject to the condition that 50%of the sites should be Government sites with 50% of patients recruited from these sites, and the Principal Investigator (PI) should be preferably an Orthopedic Surgeon. Furthermore, the expert panel stated that in the exclusion criteria Vit. D deficiency needs to be treated before including the patient in the study.
"Vit. D dose should be 1000 IU instead of 400 IU as part of standard treatment" the expert panel added.
This came after the drug major Lupin presented Phase III clinical trial protocol number –IRO2201A301, version no-2.1, dated 12 April 2023 before the committee.
Denosumab is a RANK ligand (RANKL) inhibitor used for the management of osteoporosis in patients at high risk for bone fractures. Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes. This can lead to a decrease in bone strength that can increase the risk of broken bones (fractures).
Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated in multiple clinical trials for the prevention and treatment of bone metastases.
Denosumab is designed to target RANKL (RANK ligand), a protein that acts as the primary signal to promote bone removal/resorption. In many bone loss conditions, RANKL overwhelms the body's natural defense against bone destruction. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
Denosumab is also known by its brand names, Xgeva and Prolia.
At the recent SEC meeting for Analgesic and Rheumatology held on 27th July 2023, the expert panel reviewed the Phase III clinical trial protocol number –IRO2201A301, version no-2.1, dated 12 April 2023.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following conditions –
1. 50% of the sites should be Government sites with 50% of patients recruited from these sites.
2. PI should be preferably Orthopedic Surgeon.
3. In the exclusion criteria Vit. D deficiency needs to be treated before including the patient in the study.
4. Vit. D dose should be 1000 IU instead of 400 IU as part of standard treatment.
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