Drugs Controller General of India (DCGI) has given its approval to an anti-COVID drug developed by Defence Research and Development Organisation (DRDO). The drug has been approved for emergency use as an adjunct therapy in moderate to severe coronavirus cases. The drug is to be administered orally.
Clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
The approval to the drug has come at a time when India has been grappling with a record-breaking wave of coronavirus pandemic that has stretched the country’s healthcare infrastructure to its limit.
The announcement of the approval was made by India’s Health Ministry
“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,” the Ministry said.
It said the anti-COVID-19 therapeutic application of 2-DG drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL) in Hyderabad.
“On May 01, DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country,” the Ministry said in a statement.
Adjunctive therapy is a treatment used together with the primary treatment to assist it.
The drug comes in powder form in a sachet and is taken orally by dissolving it in water.
“It 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,” the Ministry said.
In terms of efficacy trends, the Ministry said, patients treated with 2-DG showed faster symptomatic cure than the standard of care (SoC) on various endpoints.
“A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC,” it said.
“Clinical trial results of the drug have shown that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients,” it added.
