India’s top drug regulatory body on Monday approved the use of the antiviral medication remdesivir for the treatment of suspected or laboratory-confirmed cases of Covid-19 in adults and children hospitalised “with severe disease”, The Indian Express has learnt.
Remdesivir is one of the most closely watched drugs in the global clinical trials to find a cure for Covid-19. The injectable medicine was approved by Drugs Controller General of India Dr V G Somani for administration as part of a maximum five-day regimen, sources said.
The drug, manufactured by the American biopharma giant Gilead Sciences, will be imported by Mumbai-based Klinera Global Services from the manufacturing sites of Gilead, Jubilant HollisterStier and Patheon Manufacturing Services in the United States, the sources said.
The regulator, Central Drugs Standard Control Organisation (CDSCO), is learned to have decided against extending the use of the drug to 10 days, based on existing evidence presented to it at the time of approval.
“As per the data presented by the company so far, administering remdesivir for 10 days as opposed to five doesn’t have any beneficial effects, so why should patients consume it for an additional five days? There is also a potential risk of the mortality rate increasing with extended use, so the authority has been more stringent with its decisions compared to other countries,” a senior Health Ministry official close to the development said on condition of anonymity.
“The approval paves the way for generic voluntary licence holders in our country to manufacture remdesivir. The restriction of administration of the drug to five days will save the patients a lot of money,” the official added.
Queries sent to Gilead were unanswered until press time on Monday. However, the firm on Monday announced the results from its Phase 3 SIMPLE trial, which found that hospitalised Covid-19 patients on remdesivir were 65 per cent more likely to see clinical improvement by the 11th day compared with those who were not on the drug.
While the odds of improvement in the condition of patients on remdesivir were also “favourable” with the use of the drug extended to 10 days, it was not drastically different, and had similar results.
Earlier treatment was suggested as a key factor in improved clinical outcomes.
Remdesivir will only be used in hospital or institutional settings and will have to be administered only with the “written informed consent” of each patient or their representative, said another source who is directly aware of the development.
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The product’s package insert would have to specify any risks related to its use in patients with renal and hepatic impairment, and how it should be administered in such a situation.
As part of the company’s risk management plan, the CDSCO has mandated a system for collecting, processing, and forwarding information on adverse drug reactions emerging from the use of the drug in India. This will have to be submitted within a month.
Results of additional clinical trials will have to be submitted to the regulator “at least” within nine months, while “active surveillance” of all patients treated with remdesivir in India would have to be submitted on a monthly basis.
Three batches of the imported consignment will be tested at the CDSCO’s Central Drugs Technical Laboratory in Mumbai.
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