1 min read.Updated: 02 Nov 2020, 08:51 PM ISTLeroy Leo
After detailed deliberation, the committee did not recommend for grant of full marketing authorisation and opined that approval for Restricted Emergency use of the drug should continue,' the expert committee's meeting states
NEW DELHI: An expert panel at Central Drugs Standard Control Organisation rejected Dr Reddy’s Laboratories’ proposal for a full approval for remdesivir, saying that the restricted emergency use for the drug should instead continue.
“After detailed deliberation, the committee did not recommend for grant of full marketing authorisation and opined that approval for Restricted Emergency use of the drug should continue," the minutes of a meeting subject expert committee on Covid-19 on Thursday showed. The minutes were made public on Monday.
Dr Reddy’s is one of the seven manufacturers in India with whom Gilead has a voluntary licensing agreement for manufacturing and sale of remdesivir in India and over 120 low- and middle-income countries. The other manufacturers are Cipla, Jubilant Life Sciences, Hetero Drugs, Mylan, Zydus Cadila and Biocon subsidiary Syngene International.
The move by the SEC comes even as the US Food and Drug Administration on 22 October gave a complete approval for Gilead Sciences Inc’s drug despite evidence from the World Health Organisation’s Solidarity Trial released last month that the drug was not effective in treating covid-19 patients.
The approval for remdesivir, which Gilead markets under the brand Veklury, was the first by the US FDA for any covid-19 drug.
The US FDA ignored the results of the Solidarity Trial, and instead focussed on three trials which showed that the drug worked. While one of the trials was by the US’ National Institute of Allergy and Infectious Diseases on mild, moderate and severe covid-19 patients, two were sponsored by Gilead itself.
The Solidarity Trial was an open-label trial of 11,266 covid-19 patients from 30 countries, of which 2,750 were allocated remdesivir. Results, which are yet to be peer-reviewed, showed little or no effect on the survival rates of covid patients.
Apart from remdesivir, the Solidarity Trial also studied the effect of hydroxychloroquine, a combination of HIV drugs lopinavir and ritonavir, as well as a combination of lopinavir and interferon. None of the other drugs showed any effect on the length of hospital stay or the mortality rate of those infected, showed the study.