Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-04-21 12:30 GMT | Update On 2024-04-21 12:30 GMT

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 maker Sanofi presented the proposal for the grant of permission to import and market of drug Belumosudil tablets 200 mg with local Phase III clinical trial waiver along with a request to consider Belumosudil as an Orphan drug as defined in NDCT Rules 2019 as the Chronic graft versus host disease (GvHD) is a rare condition affecting less than 1000 patients in India.

Belumosudil tablets 200 mg are approved in the US, Canada, Great Britain, Australia, China, and Israel. Belumosudil is designated as a breakthrough therapy by the US FDA and also granted priority review in the US and Canada.

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.

At the recent SEC meeting for Haematology held on 19th March 2024, the expert panel reviewed the proposal presented by the drug major Sanofi for the grant of permission to import and market Belumosudil tablets 200 mg with local Phase III clinical trial waiver along with a request to consider Belumosudil as an Orphan drug as defined in NDCT Rules 2019.

After detailed deliberation, the committee opined that Chronic graft-versus-host disease (GvHD) is a rare condition and there is an unmet need in the country.

However, the committee opined that: -

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.

Accordingly, the expert panel suggested that the firm should submit the post-marketing safety data of the drug Belumosudil from all the countries where the drug Belumosudil is approved for marketing and Phase IV clinical trial protocol before the committee for further consideration.

Also Read:Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi

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