Atleast 50% more geographically distributed Govt sites be included: CDSCO panel Tells IQVIA in Milvexian study

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-04-03 12:30 GMT | Update On 2024-04-03 12:30 GMT

New Delhi: Reviewing the proposal presented by IQVIA regarding the waiving of the specific condition in the Milvexian study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined IQVIA that the condition may be modified as “At least 50% more geographically distributed and Government sites should be included in the study".

This came after IQVIA presented a waiver to condition No.1 i.e. 50% of sites should be Govt. sites and 50% of trial subjects should be enrolled in these Govt. sites protocol No. 70033093AFL3002. It is a study of Milvexian versus Apixaban in participants with Atrial Fibrillation.

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

Milvexian is a factor XIa inhibitor which acts as an anticoagulant. It is taken by mouth. As of late 2021, it was understudy for the prevention of blood clots in patients undergoing surgery.

Milvexian is a potent small molecule that inhibits the active form of FXIa with high affinity. This molecule is one of the first oral FXIa inhibitors being developed as a new potential antithrombotic drug.

At the recent SEC meeting for Cardiovascular and Renal held on 7th March 2024, the expert panel reviewed the proposal presented by IQVIA.

After detailed deliberation, the committee recommended that condition No. 1 may be modified as “At least 50% more geographically distributed Government sites should be included in the study.

Also Read: Drug safety alert: CDSCO flags 58 drug samples

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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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Atleast 50% more geographically distributed Govt sites be included: CDSCO panel Tells IQVIA in Milvexian study

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