Death During Glenmark Favipiravir-Umifenovir Trial: CDSCO seeks adverse event report

The median time to clinical cure improved by only 1 day (7 as compared to 8) in patients who received the two antiviral combinations, which was not statistically significant and did not justify adding two antiviral agents.

The firm presented the result of the clinical trial before the Subject Expert Committee (SEC) functional under the CDSCO.

However, from the results, it was observed that there is no superiority of Favipiravir and Umifenovir combination over Favipiravir alone. Commenting on the trial's findings, Monika Tandon, Senior Vice President, and Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark had stated, "These latest findings confirm that the addition of Umifenovir does not show any incremental benefit in clinical outcomes. Thus Favipiravir therapy along with supportive care remains a suitable and effective choice for mild to moderate Covid-19 infection."

Also Read: Combining Umifenovir, Favipiravir For Mild COVID Treatment Did Not Show Benefit: Glenmark

The expert panel clarified, "The firm has also decided to withdraw their proposal for market authorization of the combination."

The committee, however, recommended that CDSCO should obtain the details of one SAE (death) reported and presented before the committee, including analysis of ethics committee, investigator and sponsor, etc for review as per the requirements.