Optimus Pharma seeks nod for Molnupiravir EUA – ET HealthWorld

Hyderabad: City-based Optimus Pharma has approached Drugs Controller General of India (DCGI) seeking emergency use authorization for Molnupiravir. The company said interim results of its Phase-3 clinical trials showed the drug was effective in reducing viral load in patients.

The company is also all geared up to begin manufacturing Molnupiravir once it gets the EUA nod from the drug regulator, Optimus Pharma chairman & managing director Dr. D Srinivasa Reddy said on Wednesday. On the Phase-3 trials, Reddy said interim results of 353 patients showed the drug was successful in reducing viral load effectively with RT-PCR negativity achieved in 78.3% patients in the test arm as compared to 48.4% in standard of care (SOC) arm on Day 5 of administering the drug.

“Day 10 and 14 of the treatment duration has also given excellent results wherein remaining patients have successfully achieved RT-PCR negativity. The trial also reveals clinical improvement in health in a significantly high proportion of patients. The safety of the drug has also been established with no observed side effects, co-morbidity or morbidity observed during and after the treatment duration,” Reddy explained.

The clinical trial has been conducted on 1218 patients suffering from mild covid-19 with patients being randomised 1:1 ratio of Molnupiravir with SOC and patients only on SOC. The treatment duration was five days and the total study duration was 28 days from randomisation.

The company has already developed in-house the active pharmaceutical ingredient (API) and formulation for Molnupiravir before obtaining the regulator’s approval for the Phase-3 trials.


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