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

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.

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