No significant Clinical Benefit with Umifenovir Addition in COVID-19 Treatment: Glenmark Clinical Study

Published : 20 Oct 2020

Drug Name : (Umifenovir+ Favipiravir)

Glenmark pharmaceuticals, a research-led, integrated world company, proclaimed 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 when the successful Favipiravir monotherapy trial earlier this year that crystal rectifier the corporate to receive the Emergency Use Authorisation for Favipiravir.

This second study titled the religion trial evaluated the potential superiority of the combination’s efficaciousness against Favipiravir monotherapy. As per the results that Glenmark these days bestowed to the regulator, the study showed no superior clinical outcomes with the addition of Umifenovir.

The FAITH study listed a complete of 158 hospitalized patients with moderate COVID-19 in the Asian nation. The study’s primary termination (clinical outcome measured) was time taken from organization to clinical cure, outlined as the resolution of baseline clinical signs and symptoms of COVID-19 infection and a minimum of a pair of purpose improvement on the WHO Ordinal Scale for Clinical Improvement, among a time-frame of twenty-eight days. The median time to clinical cure improved by only one day (7 as compared to 8) in patients WHO received the 2 antiviral mixtures, that wasn't statistically important and didn't justify adding 2 antiviral agents. Commenting on the trial’s findings, Dr. Monika Tandon, Senior VP & Head, Clinical Development, world Specialty/Branded Portfolio, Glenmark prescription drugs Ltd., said, “Glenmark was the primary company to supply patients associate oral antiviral treatment for COVID-19 in an Asian nation, and this mixed study was one more effort on our half to look at new treatment choices to combat the health crisis. These latest findings ensure that the addition of Umifenovir doesn't show any progressive profit in clinical outcomes. therefore Favipiravir medical aid beside ancillary care remains an appropriate & effective selection for gentle to moderate COVID-19 infection.”

In June 2020, Glenmark became the primary company in the Asian nation to receive producing and promoting approval for FabiFlu as a part of the accelerated approval method, considering the emergency of the COVID-19 happening within the country. Glenmark with success developed the active pharmaceutical ingredient (API) and also the formulation for the oral antiviral through its in-house R&D team.

Source: GlobalData.com