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DCGI okays DRDO's anti Covid drug emergency use

 Rohit Shishodia

The Drugs Controller General of India has approved the anti-Covid drug developed by scientists of the Defense Research and Development Organization (DRDO) in association with Dr Reddy’s Laboratories, Hyderabad.

The drug was developed at the Institute of Nuclear Medicine and Allied Sciences (INMAS), a DRDO lab. The approval was given based on phase-3 clinical trials that showed promising results on managing moderate to severe Covid patients

The DCGI has said that the drug comes in powder form in a sachet, which 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. In the ongoing 2nd wave of corona pandemic, a large number of patients are facing severe oxygen dependency and need hospitalization.

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 and burden on health infrastructure of the country.

A draft press release issued by DCGI reads that clinical trial results have shown that this anti-Covid-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) helps in faster recovery of hospitalized patients and reduces supplemental oxygen dependence.

“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 in the ongoing pandemic,” it says.

According to the DCGI, DRDO had taken the initiative of developing anti-Covid therapeutic application of 2-DG. In April 2020, during the first wave of pandemic INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad, and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth.

The DCGI has said that based on these results it permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May 2020. DRDO, along with its industry partner Dr Reddy’s Laboratories (DRL, Hyderabad), started the clinical trials to test the safety and efficacy of the drug in Covid-19 patients.

In Phase- II trials (including dose ranging) conducted during May 2020 to October 2020, the drug was found to be safe in Covid-19 patients, and showed significant improvement in their recovery. Phase IIa was conducted in 6 hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country.

Phase-II trial was conducted on 110 patients. In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favorable trend (2.5 days difference) was seen in terms of the median time to achieving normalization of specific vital signs parameters when compared to SOC.

Based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients during Dec 2020 to March 2021 on a large number of patients at 27 Covid hospitals situated in states of Delhi, UP, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.

The detailed data of phase-III clinical trials was presented to DCGI. In the 2-DG arm, significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by day-3 in comparison to SOC, indicating an early relief from Oxygen therapy/dependence.

The similar trend was observed in patients more than 65 years also. On May 1, 2021, 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.


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