DCGI gives emergency use approval for DRDO’s anti-COVID drug 2-DG
The Drugs Controller General of India (DCGI) has given emergency use approval for 2-deoxy-D-glucose (2-DG) of Defence Research and Development Organisation (DRDO) for the treatment of Covid-19.
The DRDO drug has been approved as an adjunct therapy in Covid-19 patients having moderate to severe infection.
As it is a generic molecule and analogue of glucose, it can be produced easily and made available in adequate quantities to tackle the ongoing second wave of Covid-19 in India.
Moreover, the 2-DG drug comes in the form of powder in a sachet, which has to be orally taken by dissolving in water.
The anti-Covid-19 drug has been developed by the Indian Ministry of Defence unit in collaboration with Dr Reddy’s Laboratories.
According to the Indian Ministry of Defence, clinical trial results of the 2-DG Covid-19 drug have demonstrated that the molecule aids in quicker recovery of hospitalized patients and cuts down dependence on supplemental oxygen.
The Ministry of Defence stated: “The Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients. The drug will be of immense benefit to the people suffering from COVID-19.”
During the first wave of the Covid-19 pandemic in India, that is April 2020, scientists of the Institute of Nuclear Medicine and Allied Sciences (INMAS), a laboratory of DRDO, carried out experiments with the help of Centre for Cellular and Molecular Biology (CCMB).
It was found in the lab experiments that the 2-DG molecule effectively works against the Covid-19 causing SARS-CoV-2 virus and prevents the viral growth. This paved the way for 2-DG phase 2 clinical trial, which was held in 110 Covid-19 patients in May 2020 in collaboration with Dr Reddy’s Laboratories.
In the phase 2 trials, which included dose ranging studies, held from May to October 2020, 2-DG was found to be safe in patients with Covid-19, while delivering considerable improvement in their recovery.
A subsequent 2-DG phase 3 clinical trial was carried out on 220 patients between December 2020 to March 2021 at 27 Covid-19 hospitals across India.
In the 2-DG patient arm, a substantially higher proportion of patients had improved symptomatically and were no longer dependent on supplemental oxygen – 42% vs 31% by Day-3 in comparison to Standard of Care (SoC).
The Ministry of Defence stated: “It (2-DG) accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.
“In the ongoing second COVID-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation. The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of COVID-19 patients.”