Death During Glenmark Favipiravir-Umifenovir Trial: CDSCO seeks adverse event report
New Delhi: The Mumbai-based drugmaker, Glenmark Pharmaceuticals Ltd., has been directed by the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) to submit details of the Serious Adverse Event (SAE), a single death, from the clinical trials of the drug combination of Favipiravir and Umifenovir.
A couple of days ago, the drugmaker had announced the results of its "FAITH" combination trial with antivirals Umifenovir and Favipiravir for the treatment of moderate hospitalized Covid-19 patients.
This was the second clinical study after the successful Favipiravir monotherapy trial earlier this year that led the company to receive the emergency use authorization for Favipiravir. This second study titled the FAITH trial evaluated the possible superiority of the combination's efficacy against Favipiravir monotherapy.
The FAITH study enrolled in 158 hospitalized patients with moderate Covid-19 in India. The study's primary endpoint (clinical outcome measured) was the time taken from randomization to clinical cure, defined as resolution of baseline clinical signs and symptoms of Covid-19 infection and at least 2-point improvement on the WHO Ordinal Scale for Clinical Improvement, within a time frame of 28 days.
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."
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.