New Delhi: A potential cancer drug from Dr Reddy’s that has reportedly shown promise in moderate-to-severe Covid-19 patients will not be allowed for emergency use yet, an expert panel of the Modi government has said.
At a meeting late last month, the subject expert committee (SEC), which advises regulator Drugs Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials, reiterated that the Hyderabad-based pharma firm should test the drug on more patients.
The reiteration came on 29 October as the SEC took up a request from Dr Reddy’s for emergency-use authorisation of their drug, 2-Deoxy-D-Glucose oral powder, also called 2-DG. At an earlier meeting on 13 October, the SEC had called for wider trials as it turned down the firm’s proposal for market authorisation that cited the results of a small, phase 2 trial.
“In light of earlier SEC recommendations dated 13.10.2020, the firm presented their proposal for approval of the drug for restricted emergency use and Phase III Clinical Trial protocol before the committee,” the minutes of the second SEC meeting, uploaded on the Central Drugs Standard Control Organisation (CDSCO) website, state.
“After detailed deliberation, committee reiterated its earlier recommendation in respect of their proposal and did not recommend for approval of the drug for restricted emergency use as no additional data was presented,” they add.
‘Test mortality risk too’
The Dr Reddy’s drug works by preventing the supply of glucose molecules to cancerous cells, which need glucose for survival. With the drug stopping the glucose supply, the cells start dying.
While the drug is not yet approved for cancer treatment, it is believed to have shown promise for Covid-19 during its phase 2 trial, which was sponsored by Dr Reddy’s and the Institute of Nuclear Medicine and Allied Sciences (INMAS), a department functioning under the Defence Research and Development Organisation (DRDO).
According to the panel’s recommendations, further trials on the efficacy of the drug should factor in the mortality risk. It said, “28 days mortality should be included as one of the efficacy end points,”
The firm, it added, should appoint a “medical monitor” for coordination and monitoring of the trial at all sites.