DCGI approves Covid drug developed by DRDO for emergency use

It said clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients

Indian drug regulator has approved an indigenous anti-cancer drug for emergency treatment of Covid-19 patients as the medicine has shown to significantly reduce the symptoms and oxygen dependence in such patients much ahead of the standard care.

Developed by scientists at the Delhi-based Institute of Nuclear Medicine and Allied Sciences, one of the DRDO laboratories, the medicine known as 2-DG received permission following two rounds of clinical trials that began in May last year. It is a cancer medicine that was repurposed for Covid-19 treatment.

“On May 1, the Drugs Controller General of India granted permission for emergency use of this drug as an 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 Central Drug Standard Control Organisation said in a press statement on Saturday.

The drug, manufactured by Dr Reddy's Laboratory, 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.

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Since a large number of patients face severe oxygen dependency and need hospitalisation in the second wave of the pandemic, the drug is expected to reduce the hospital stay of Covid-19 patients and burden on health infrastructure.

In the third phase of the clinical trial carried out on 220 patients at 27 hospitals in 10 states including Karnataka, the medicine has not only significantly lowered the symptoms of Covid-19 patients but also reduced the oxygen dependency in 42% of patients after three days. The standard care, on the other hand, led to the reduction of supplemental oxygen dependence in 31% of patients.

In Phase-II trials conducted from May to October 2020, the drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery. Phase IIa of the trial was conducted in six hospitals while phase IIb was conducted at 11 hospitals all over the country. Taken together, the 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 on various endpoints. A significantly favourable trend was to achieve normalisation of specific vital signs 2.5 days ahead of the standard treatment.