Hyderabad-based Optimus Pharma has applied to the Drugs Controller General of India (DCGI) for an emergency use authorization for Molnupiravir. The business stated that preliminary findings of its Phase-3 clinical studies revealed that the medication was successful in lowering 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.
