New Delhi: Mumbai-based drug maker Cipla has submitted a proposal before the government’s subject expert committee (SEC) to change remdesivir’s composition in order to reduce the drug’s adverse effects on the kidneys.
Antiviral medicine remdesivir is one of the most closely watched drugs in the global clinical trials against the Covid-19 disease.
In a meeting held on 17-18 December, the SEC had asked the company to conduct a bioequivalence study i.e., compare different proprietary preparations of the same drug — one which is presently available in the market and another with the proposed changes.
“SEC in the meeting noted that in the proposed formulation SBECD (sulfobutylether-b-cyclodextrin) is replaced with Polysorbate 80 and PEG 300 with the intention to reduce the renal toxicity,” read the minutes of the meeting, uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website Tuesday.
The CDSCO is the health ministry arm that regulates quality of drugs and vaccines in the country while the SEC advises the Drugs Controller General of India on applications seeking approvals for new drugs and vaccines.
SBECD is used to make drugs more soluble for intravenous administration, whereas polysorbate is a thickening agent that is used in personal care products and also as a food additive. PEG is used as an inactive substance in drug manufacturing, as a vehicle for drug transportation in the human body.
Along with the bioequivalence study, the SEC has also asked Cipla to conduct clinical trials to assess renal toxicity of the new formulation.
“Accordingly, the firm should submit bioequivalence study protocol and clinical trial protocol to CDSCO for further review by the committee,” the minutes of the meeting noted.
Cipla refused to comment on the proposal when ThePrint reached the company via email and text messages.
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Remdesivir’s effects on kidneys
The possible impact of remdesivir on the kidneys is not yet known but an assessment of renal function in Covid‐19 patients is recommended before and during treatment with remdesivir.
The European Medicines Agency, which is responsible for regulating drugs in the continent, had in October announced that it will determine whether there was a causal relationship between acute kidney injury and remdesivir.
According to a study published in Journal of American Society of Nephrology, animal studies have associated SBECD accumulation with liver and renal diseases. However, these had occurred in animals at doses 50 to 100 times higher than expected in a five- to 10-day remdesivir course.
The study, however, also said that “available data from a single randomized, controlled trial in Covid-19 did not demonstrate an increased risk of renal adverse events in patients randomized to receive remdesivir”.
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