Submit interim analysis results of study in Russia and India: CDSCO panel Tells Lupin Over Aflibercept
New Delhi: In response to the proposal to enroll an additional 298 patients from India in the study of the ophthalmic drug Aflibercept, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Lupin to submit interim analysis results of the study in Russia and India before the committee for further review.
This came after the drug major Lupin presented their proposal for protocol no, LRP/LUBT017/2021/003 version 1.0, dated 14 March 2022 to enroll the additional 298 patients from India.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor used to treat Neovascular (Wet) Age-Related Macular Degeneration (AMD), various types of macular edema, and diabetic retinopathy.
Aflibercept is in a class of medications called vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) antagonists. It works by stopping abnormal blood vessel growth and leakage in the eye(s) that may cause vision loss in people with certain eye conditions.
Ablibercept is a recombinant fusion protein that acts as a decoy receptor for the ligands, vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PIGF). It prevents these ligands from binding to endothelial receptors, VEGFR-1 and VEGFR-2, to suppress neovascularization and decrease vascular permeability. This ultimately will slow vision loss or the progression of metastatic colorectal cancer.
At the recent SEC meeting for Ophthalmology held on 22 August 2023, the expert panel reviewed the proposal for protocol no, LRP/LUBT017/2021/003 version 1.0, dated 14 March 2022, presented by drug major Lupin to enroll an additional 298 patients from India
After detailed deliberation, the committee recommended that the firm should submit interim analysis results of the study in Russia and India before the committee for further review.
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