Tribune News Service
New Delhi, October 24
The World Health Organisation has warned drug regulators across the world against ignoring its “robust” evidence on little or no benefit of anti-viral Remdesivir in patients hospitalised with Covid19.
The warning came from WHO chief scientist Soumya Swaminathan after the US Food and Drug Administration (FDA) this Thursday granted full approval to Gilead Sciences Inc’s Remdesivir for treating hospitalised Covid patients.
The WHO-led largest Solidarity Trials that tested Remdesivir among Covid patients found that the drug neither improved survival nor reduced the duration of stay in the hospital.
“We believe our results are very robust. We hope that people who are doing treatment guidelines in other countries as well as regulators across the world will take note of our results in addition to the other evidence… because you need to look at global evidence for a drug before you make decisions,” Swaminathan said.
She noted that the FDA appears to have “not considered the WHO solidarity trial results on Remdesivir” before granting its full approval to the drug.
The WHO trial, which ran through March 22 to October 4, 2020, and followed 11,266 patients in 405 hospitals across 30 countries in all six WHO regions, found that Remdesivir had “little or no effect on hospitalised Covid19 patients as indicated by overall mortality, initiation of ventilation and duration of hospital stay”.
It said the study drug did not appreciably reduce initiation of ventilation in those not already ventilated.
The FDA, however, while approving anti-viral drug Veklury (Remdesivir) for use in adult and paediatric patients 12 years of age and older and weighing at least 40 kg, said, “Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”
Veklury is the first treatment for Covid to receive FDA approval. FDA approvals followed Gilead’s own results of trials on 1062 people that said Remdesivir cut recovery time by five days and reduced risk of death in patients receiving oxygen support.
First to get US FDA’s approval
- Veklury (Remdesivir) is the first treatment for Covid-19 that has received the US FDA’s approval
- The approval followed manufacturing firm Gilead Sciences Inc’s own trials on 1,062 persons
- It said Remdesivir cut recovery time by five days and reduced mortality among patients on oxygen support
- Indian Covid task force currently allows the use of this drug among investigational therapies
Delhi Chief Minister Arvind Kejriwal for free vaccine throughout country
- Delhi Chief Minister Arvind Kejriwal on Saturday said the Covid-19 vaccine should be made available throughout the country for free, saying all people were troubled by the virus
- “The whole country should get free Covid-19 vaccine. It is the right of the entire country,” he added
- He ruled out reopening of schools in the national capital for now. PTI