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DCGI approves anti-COVID drug developed by DRDO for emergency use

The Drugs Controller General of India (DCGI) has granted permission for emergency use of anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s Laboratories (DRL),Hyderabad. 

In a release issued on Saturday, the Ministry of Defence said that as per the order, emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients is permitted. It added that being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country. 

The drug comes in powder form in 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.

Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence, noted the release.

It further said that higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID-19 patients. 

“The drug will be of immense benefit to the people suffering from COVID-19,” said the Ministry.

In April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of the 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 permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.

The DRDO, along with its industry partner 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 to October 2020, the drug was found to be safe in COVID-19 patients, and showed it led to significant improvement in their recovery. Phase IIa was conducted in six 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, patients treated with 2-DG showed faster symptomatic cure than 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.

Based on successful results, the DCGI further permitted Phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 COVID-19 hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of the phase-III clinical trial was presented to the DCGI. In the 2-DG arm, significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% versus 31%) by Day 3 in comparison to SoC, indicating an early relief from oxygen therapy/dependence.

The similar trend was observed in patients aged more than 65 years, noted the release.

Courtesy – TheHindu

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