NEW DELHI: Hopes have grown for approval of India’s first antiviral drug Covid-19 with two drugmakers reaching regulator, Central Drugs Standard Control Organization, with molnupiravir Phase 3 clinical trial data and requesting a marketing authorization for the pill.
Called very promising in the treatment of coronavirus infection, the drug is said to clear the viral infection in about five days in mostly mild cases, preventing many people from progressing to a serious medical condition. “Indian companies have submitted data from phase 3 clinical trials of the drug and the Covid19 expert committee will soon consider their applications,” a senior CDSCO official told the newspaper.
In India, five companies had entered into voluntary licensing agreements to produce generic versions of the drug. The antiviral drug is also under evaluation by the US FDA for its efficacy and safety, and an FDA advisory committee is due to meet next month to consider Merck and Ridgeback’s request for authorization to use the drug. emergency for molnupiravir to treat mild to moderate Covid. 19.
Merck, the original US-based developer of the broad-spectrum oral antiviral drug, reported this month that the drug had halved the rate of hospitalizations and deaths among high-risk Covid patients who had it. taken soon after infection in a large clinical trial.
Molnupiravir, like remdesivir, is a nucleoside analogue, which means that it mimics some of the building blocks of RNA. This antiviral gets incorporated into the growing strands of RNA and, once inside, begins to kill the virus.
Last month, the two drugmakers independently testing generic molnupiravir in India, Natco Pharma and Hetero, in people with moderate Covid disease, however, said they had not seen any “significant efficacy” for the drug. investigational drug although they have continued trials in humans. with mild illness.
But this, according to virologists, is in line with expectations, because the sicker the patient, the less effective the drugs are in treating the disease. “A pill would just require a prescription. It will be a game-changer because it will prevent people from landing in hospitals, ”said a virologist from the Indian Council for Medical Research.