Dr Reddy’s Laboratory on Monday, 28 June, announced the commercial launch of the anti-Covid drug, 2-Deoxy-D-Glucose (2-DG) for hospitalised moderate to severe Covid-19 patients.
The drugmaker said it will supply to major government as well as private hospitals across India.
In the initial weeks, the Company will make the drug available in hospitals across metros and Tier 1 cities, and subsequently expand coverage to the rest of the country, it said.
The maximum retail price of each sachet has been fixed at Rs 990, with a subsidized rate offered to government institutions.
The treatment which was developed by the Defence Research and Development Organisation (DRDO) in collaboration with Dr Reddy's Laboratory involves the 'therapeutic application of the drug 2-deoxy-D-glucose (2-DG)' for moderate to severe COVID cases.
It was granted emergency use authorisation by The Drug Controller General of India (DCGI) on 7 May.
On 17 May, the first batch of the drug was launched by the Union Defence Minister, Rajnath Singh.
In an earlier statement, the Ministry of Defence has said, "clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence."
This treatment, the ministry hopes, will help combat the severe oxygen dependency and hospitalisation that has been rampant in the second wave.
But how robust is the study? And why are many experts not convinced?
What is this Drug?
DRDO-Dr Reddy's drug involves the therapeutic application of 2-deoxy-D-glucose (2-DG), a glucose molecule for the treatment of COVID.
The particular drug will be available in powder form and is meant to be dissolved in water and administered orally.
Once consumed, it spreads throughout the body and works on the virus infected cells in a targeted manner, says DRDO.
"It accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production."The Ministry of Defence
They also add that "its selective accumulation in virally infected cells makes this drug unique."
Dr Sudhir Chandna, a scientist at the Institute of Nuclear Medicine and Allied Sciences (INMAS)-DRDO, has said that the drug is safe and should be available for use by next month, reported Mint.
Limitations With Clinical Trials
Laboratory experiments by DRDO in collaboration with Centre for Cellular and Molecular Biology (CCMB) is said to have started in April last year.
Based on the data collected in this, the DCGI granted permission to take it forward and conduct phase 2 clinical trials to test the safety and efficacy of the drug in May 2020.
The emergency use approval was granted to the drug based on data from phase 3 clinical trials which was presented to the DCGI.
The phase 3 clinical trials were conducted in November and involved 220 participants across 27 COVID hospitals in 10 states.
According to their statement, during this trial, by day 3, 42 per cent of the participants in the 2-DG arm improved symptomatically and became free from supplemental oxygen dependence, as compared to the 31 per cent in the group that received standard care.
Similar results have also said to have been observed in those over the age of 65 years.
Why are Researchers Not Convinced?
Some researchers have questioned the opacity of the drug's primary trial results and the lack of peer-reviewed research papers available in the public domain.
Dr Reeteka Sud, Neuroscientist at NIMHANS Bangalore, among other researchers, has pointed to the lack of access to the data from the clinical trials.
Others have pointed to the inadequate sample size used in the phase 3 trials that involved 220 participants when, according to the US FDA, the number should usually range between 300-3000.
Researchers have also pointed to the unsatisfactory description of the primary outcome of the trial.
Dr Varun C, explains the problem with this in a Twitter thread. He says when primary endpoints (what is the trials meant to achieve) are not recorded at the beginning of the trial, it allows the makers to point out at any possible outcomes as its end point post trials.
It has also been pointed out that 2-deoxy-D-glucose is an already existing drug used for cancer treatment.
While it is laudable that the DRDO and their research partners were able to repurpose the drug for treating COVID, to claimed they 'developed' it, or that it is a 'new drug' (like many media outlets are doing) would be unethical.
And while having an anti-COVID medicine as this—which is both easy to produce and administer— that could reduce dependency on oxygen and hospitalisation would be a godsend at the point we're at, the data will have to be published and reviewed before its safety and efficacy can be fully assessed and accepted.
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