Include Ankle Brachial Index test to exclude peripheral artery disease: CDSCO Panel Tells Lupin on Denosumab PK/PD study
New Delhi: The drug major Lupin has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a pharmacokinetic and pharmacodynamic study (PK/PD) to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects.
However, this approval is subject to a condition that the screening tests must include an Ankle Brachial Index test to rule out peripheral artery disease in exclusion criteria.
This came after the drug major Lupin presented the protocol to conduct a PK/PD study titled “Single dose study to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects” vide Protocol No. C1B03215, Version 01 dated 15 Jun 23.
Denosumab injection is in a class of medications called Receptor activator of nuclear factor kappa-Β ligand (RANK ligand) inhibitors.
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 injection is used to treat osteoporosis (thinning of the bones) in women who have an increased risk for fractures after menopause, and osteoporosis in men. It is given when other medicines cannot be used or after other medicines do not work well.
At the recent SEC meeting for analgesic and rheumatology held on 8th and 9th November 2023, the expert panel reviewed the protocol presented by drug major Lupin to conduct PK/PD study titled “Single dose study to compare pharmacokinetic, pharmacodynamic, and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects” vide Protocol No. C1B03215, Version 01 dated 15 Jun 23.
After detailed deliberation, the committee recommended for conduct of the PK/PD study as presented by the firm with the condition that screening tests must include an Ankle Brachial Index test to rule out peripheral artery disease in exclusion criteria.
Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO.
