Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi
New Delhi: Responding to the proposal presented by the drug major Sanofi to import and market Belumosudil tablets 200 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the post-marketing safety data of Belumosudil from all the countries where the drug is approved for marketing.This came after the drug...
New Delhi: Responding to the proposal presented by the drug major Sanofi to import and market Belumosudil tablets 200 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the post-marketing safety data of Belumosudil from all the countries where the drug is approved for marketing.
Belumosudil is an oral inhibitor of rho-associated coiled-coil-containing protein kinases (ROCK) used in the treatment of chronic graft-versus-host disease (GVHD).
Graft-versus-host disease (GvHD) is a systemic disorder that occurs when the graft's immune cells recognize the host as foreign and attack the recipient’s body cells. “Graft” refers to transplanted, or donated tissue, and “host” refers to the tissues of the recipient. It is a common complication after allogeneic hematopoietic stem cell transplant (HCT)
Belumosudil is indicated for the treatment of chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years of age and older following failure of at least two other lines of systemic therapy. Chronic graft-versus-host disease (GVHD) is a life-threatening complication of allogeneic hematopoietic stem cell transplantation in which the transplanted donor T-cells recognize the recipient's tissues as foreign and mount an immune response.
1. The firm should submit the post-marketing safety data from all the countries where Belumosudil is approved for marketing.2. The firm should submit proper interventional Phase IV clinical trial protocol with adequate methodology and sample size.
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