Hyderabad-based Optimus applies for molnupiravir EUA with DCGI
Hyderabad: Optimus, which has completed molnupiravir oral capsule phase 3 clinical trial, has applied for emergency use authorization (EUA) for the drug with the Drugs Controller General of India (DCGI).
On May 18, 2021, the Hyderabad-based company received approval from the DCGI to conduct the phase 3 trial as per the recommendations of the subject expert committee (SEC) of the CDSCO, DGHS, Ministry of Health and Family Welfare.
The pharmaceutical company was the first to file for the phase 3 clinical trial of molnupiravir with the central licensing authority. The clinical trial partner of Optimus, JSS Research was tasked with the execution of the trial. The trial was conducted in 29 study sites across India to prove the superiority of molnupiravir over the standard treatment options as well as its efficacy.
Dr D Srinivas Reddy, CMD, Optimus Pharma said, the company aims to develop a cutting-edge and affordable treatment option for Covid-19 and neutralise the disease in minimum treatment duration.
The phase 3 trial data of Optimus showed on the fifth day of the study that 78.4 per cent of the patients in the treatment group were recorded RT-PCR negative as compared to 48.2 per cent in the placebo group. On the 10th day of the study, 91.5 per cent of the patients in the treatment group were recorded RT-PCR negative as compared to 43 per cent in the placebo group.
“These results are not only a new hope to neutralise Covid-19 but also reinforce our belief in the central licensing authority of India to ensure a fair and legitimate trial and provide the necessary support for a self-reliant pharmaceutical industry,” he added.
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