The United States Food and Drug Administration (FDA) on Thursday approved Veklury (remdesivir), an antiviral developed and patented by Gilead Sciences, for Covid-19 treatment of hospitalised adults and children above the age of 12 years. This is the first and only treatment so far to receive the American drug regulator’s approval for Covid-19.
The nod, coming a week after interim results of a global trial sponsored by the World Health Organization (WHO) said remdesivir was ineffective in preventing Covid-19 deaths in hospitals, was given on the basis of other trials.
Remdesivir, like other repurposed drugs, had been administered to patients across the world on the basis of emergency use approvals by regulators in various countries, including India. Veklury has been approved or authorised for temporary use as a Covid-19 treatment in nearly 50 countries, according to Gilead Sciences.
“The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19,” said a US FDA release on the matter.
The trials taken into account include the ACTT-1 randomised, double-blind, placebo-controlled trial conducted by the National Institute of Allergy and Infectious Diseases. This trial looked at 1,062 hospitalised patients with mild-to-severe Covid-19 to evaluate how long it took them to recover within 29 days of being treated.
“The median time to recovery from Covid-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group,” stated the release.
Over five drug makers here, including Dr Reddy’s Laboratories, Cipla and Hetero Healthcare, have signed agreements with Gilead to make and supply generic versions of the patented drug in India as well as many low- and middle-income nations. However, the future of the drug is still being assessed in India, especially after the interim results of the WHO-sponsored Solidarity Therapeutics trial last week that said remdesivir and other repurposed drugs under study seemed to have “little or no effect” on hospitalised patients.
“This trial has just been put up (made public), their interim results have been put up on the website. This has not yet been peer reviewed, however, we find that these drugs are not performing as we had expected,” Dr Balram Bhargava, Director General, Indian Council of Medical Research said on October 20, during a briefing on the actions taken by the government to tackle Covid-19.
“So, debate and discussion is ongoing at the national task force and the joint monitoring group and we will take into cognisance results of these trials and issue the advisories accordingly,” he said.
Meanwhile, some Covid-19 doctors said they found the drug beneficial in cutting down treatment timelines in some cases. Others are waiting on the final results of the trial to take a call on if and how they will use this drug.
The size of the remdesivir market in India was pegged at around Rs 121.29 crore in the 12 months ended September, according to estimates by pharmaceutical market research firm AIOCD Awacs PharmaTrac. However, these calculations were made using data available for only four of the several remdesivir brands — Desrem (Mylan), Remdac (Zydus Cadila), Cipremi (Cipla) and Covifor (Hetero), which means the size of the market may actually be much higher.
Sales of remdesivir here have risen substantially — nearly 96 per cent in July-September for the four aforementioned brands — PharmaTrac data showed.
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