Optimus Pharma seeks nod for Molnupiravir EUA, Well being Information, ET HealthWorld


Optimus Pharma seeks nod for Molnupiravir EUAHyderabad: Metropolis-based Optimus Pharma has approached Medicine Controller Common of India (DCGI) in search of emergency use authorisation for Molnupiravir. The corporate mentioned interim outcomes of its Section-3 medical trials confirmed the drug was efficient in decreasing viral load in sufferers.

The corporate can also be all geared as much as start manufacturing Molnupiravir as soon as it will get the EUA nod from the drug regulator, Optimus Pharma chairman & managing director Dr D Srinivasa Reddy mentioned on Wednesday. On the Section-3 trials, Reddy mentioned interim outcomes of 353 sufferers confirmed the drug was profitable in decreasing viral load successfully with RT-PCR negativity achieved in 78.3% sufferers within the check arm as in comparison with 48.4% in commonplace of care (SOC) arm on Day 5 of administering the drug.

“Day 10 and 14 of the therapy period has additionally given wonderful outcomes whereby remaining sufferers have efficiently achieved RT-PCR negativity. The trial additionally reveals medical enchancment in well being in a considerably excessive proportion of sufferers. The security of the drug has additionally been established with no noticed uncomfortable side effects, co-morbidity or morbidity noticed throughout and after the therapy period,” Reddy defined.

The medical trial has been performed on 1218 sufferers affected by gentle Covid-19 with sufferers being randomised 1:1 ratio of Molnupiravir with SOC and sufferers solely on SOC. The therapy period was 5 days and the entire research period was 28 days from randomisation.

The corporate has already developed in-house the energetic pharmaceutical ingredient (API) and formulation for Molnupiravir earlier than acquiring the regulator’s approval for the Section-3 trials.

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