Hetero seeks EU Authorisation from DCGI for Molnupiravir

The median time to clinical improvement was eight days in Molnupiravir group as compared to 12 days in the control group.

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DCGI CDSCO

Last Updated on July 12, 2021 by The Health Master

HYDERABAD: The Hyderabad-based Hetero Drugs announced interim results from Phase III clinical trials of Molnupiravir in treatment of mild C-19 patients on Friday, July 9, 2021, seeking emergency use authorisation for the drug from the Drug Controller General of India (DCGI).

In a press statement, the company informed that the Phase III clinical trials were conducted at different sites across the country and involved 741 mild C-19 patients. It said that early clinical improvement was observed among the patients on Molnupiravir as compared to the control group.

The median time to clinical improvement was eight days in Molnupiravir group as compared to 12 days in the control group. 

Hospitalisations were fewer in the Molnupiravir group (1.89%) as compared to the control group (6.22%), and earlier RT-PCR negativity was also observed in the Molnupiravir group, it said.

All adverse events reported in the Molnupiravir group were of non-serious nature, mild in severity and none led to drug discontinuation. The most common adverse events reported were nausea, diarrhoea and headache which were resolved completely, it added.

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