SEC asks CDSCO to submit adverse event report of death during Umifenovir trial
It should include analysis of the ethics committee, investigator and sponsor etc., for review
The Subject Expert Committee (SEC) has asked CDSCO to submit data of the reported serious adverse event (SAE), a single death, from the clinical trials of the drug combination of Favipiravir + Umifenovir by Glenmark Pharmaceuticals.
In a recently held SEC meeting, it was informed that Glenmark Pharmaceuticals presented the result of the FAITH clinical trial of Favipiravir + Umifenovir before the committee. However, from the results, it was observed that there is no superiority of Favipiravir + Umifenovir combination over Favipiravir alone.
“The firm has also decided to withdraw their proposal for market authorisation of the combination,” informed the SEC.
Thereafter, the committee has recommended to the Indian drug regulating authority to obtain the details of one SAE (death) reported and present it before the committee, including analysis of the ethics committee, investigator and sponsor etc. for review as per the requirements.
Commenting on the SEC recommendations to the CDSCO, Amar Jesani, Editor, Indian Journal of Medical Ethics said, “The subject expert committee should have demanded the information of all the serious events, not just one death that happened during the clinical trial of combination drug of Favipiravir + Umifenovir. Likewise, they should have also asked for the opinion of the ethics committee, investigators and the sponsor about the relatedness of these SAEs to the experimental drugs.”