At the Central Drugs Standard Control Organisation, a subject expert committee (SEC) rejected Dr. Reddy’s Laboratories’ proposal for full marketing authorization of the antiviral drug, Remdesivir. They also added that the restricted emergency use of the drug should instead continue.
“After detailed deliberation, the committee did not recommend for grant of full marketing authorization and opined that approval for Restricted Emergency use of the drug should continue,” said a subject expert in the SEC meeting. If the CDSCO accepts the recommendation, it would mean that India will not be following the US’ FDA’s lead in granting full marketing approval for Remdesivir.
The Drugs Controller General of India (DCGI) approved Remdesivir for restricted use in treating CoVID-19 patients who show severe symptoms. After a licensing agreement took place between Dr. Reddy’s and Gilead Sciences, Dr. Reddy’s launched a generic version of Remdesivir under the Redyx brand.
Dr. Reddy’s had presented clinical data and sought a change in Remdesivir’s regulatory approval status to full marketing authorization. Gilead has made a voluntary licensing agreement for the manufacturing and sale of Remdesivir with seven Indian manufacturers. These include Dr. Reddy’s, Cipla, Jubilant Life Sciences, Hetero Drugs, Mylan, Zydus, Cadila, and Biocon subsidiary Syngene International. The agreement is for the manufacturing and sale of Remdesivir in India and over 120 low- and middle-income countries.
US FDA has approved Remdesivir as a recognized COVID-19 treatment
This news comes almost two weeks after the US Food and Drug Administration approved the drug as a recognized CoVID-19 treatment on October 22. Nonetheless, the World Health Organisation’s (WHO) Solidarity Trial released evidence a month ago that the drug was not effective in treating CoVID-19 patients.
WHO’s Solidarity Trial was an open-label trial of CoVID-19 patients from 30 countries. There were a total of 11,266 CoVID-19 patients, of which Remdesivir was allocated to 2,750 of them. The results showed little or no effect on their survival rates. Though, the results are yet to be studied. The Solidarity Trial also studied the effect of Hydroxychloroquine, a combination of HIV drugs Lopinavir and Ritonavir, and the combination of Lopinavir and Interferon. According to the study, none of these drugs showed any effect on the hospital stay duration or the mortality rate of the infected.
The US FDA decided to ignore WHO’s Solidarity Trial and rather focused on three trials of their own. These trials showed that the drug worked. The US’ National Institute of Allergy and Infectious Diseases conducted one of the trials on mild, moderate, and severe CoVID-19 patients. Gilead sponsored the other two trials themselves. Remdesivir’s approval marks the first by US FDA for any CoVID-19 drug. Gilead markets the drug under the name Veklury.