Updated: October 29, 2021 7:59:31 am
OPTIMUS GROUP has announced the successful completion of the Molnupiravir oral capsule phase 3 clinical trial. Molnupiravir is a new oral treatment for individuals with Covid-19 infection. The experimental antiviral drug is being evaluated by US FDA for its effectiveness and safety.
The advisory committee will meet on November 30 to take up Merck and Ridgeback’s request for granting EUA for molnupiravir to treat mild to moderate Covid infection.
On May 18, 2021, it received approval from the Drugs Controller General of India (DCGI) to conduct the trial according to the recommendations of the subject expert committee (SEC) of the CDSCO, DGHS, Ministry of Health and Family Welfare.
In a statement issued on Thursday, the pharmaceutical company said that it was the first to file for Phase 3 clinical trial of molnupiravir with the Central Licensing Authority. There were 29 study sites across the country.
“Optimus is prepared to ensure manufacturing and distribution of molnupiravir efficiently and effectively,” Dr D Srinivas Reddy, Chairman and Managing Director Optimus Pharma said.
According to the final clinical trial report, the study found that on the fifth day, 78.4% of the patients in the treatment group were recorded RT-PCR negative compared to 48.2% in the placebo group. On the 10th day, 91.5% of the patients in the treatment group were recorded RT-PCR negative compared to 43% in the placebo group.
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