Syngene International Gets CDSCO Panel Nod To study Trinbelimab Injection

However, the nod came with conditions that the title of the study should be amended to include Rh-D negative non sensitized postmenopausal female subjects.

Furthermore, the expert panel suggested that the exclusion criteria should be modified so that Rh-D negative sensitized women are excluded from participation in the study.

This came after the firm presented the Phase I protocol titled “A prospective, single-dose, single-period study to evaluate the pharmacokinetics and tolerability of Trinbelimab (recombinant anti-rho-d immunoglobulin) of Bharat Serums and Vaccines Ltd., India in healthy, adult, rhesus negative postmenopausal female subjects” vide protocol no SYNCD-003-23 version no 2.00 dated 10.04.2023.

Trinbelimab is in a class of medications called monoclonal antibodies. It prevents antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive.

At the recent SEC meeting Reproductive & Urology held on 20th July 2023, the expert panel reviewed the Phase I protocol titled “A prospective, single-dose, single-period study to evaluate the pharmacokinetics and tolerability of Trinbelimab (recombinant anti-rho-d immunoglobulin) of Bharat Serums and Vaccines Ltd., India in healthy, adult, rhesus negative postmenopausal female subjects” vide protocol no SYNCD-003-23 version no 2.00 dated 10.04.2023.

After detailed deliberation, the committee recommended conducting the Phase I study subject to the following changes in the protocol-

1. The title should be amended to include Rh-D negative non-sensitized postmenopausal female subjects.

2. The exclusion criteria should be modified so that Rh-D negative sensitized women are excluded from participation in the study.

Accordingly, the committee suggested that the firm should submit a revised protocol to CDSCO for further approval.

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