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SA health regulator gives emergency go-ahead for chloroquine importation

A local pharmaceutical company has received permission from the medical regulator to import half a million chloroquine phosphate tablets for use in severely ill COVID-19 patients, reports Business Day. Austell Laboratories, which is based in Parktown in Johannesburg and describes itself as the largest privately owned pharmaceutical company in the country, said this week it will donate 50,000 of boxes of 10 tablets to the department of health for state use.

Working with Austell, the report says the Health Department applied to the South Africa Health Products Regulatory Authority for special emergency permission to import the drug from a new Indian supplier – and was quickly granted it.

Chloroquine is being used by doctors globally in the treatment of extremely sick COVID-19 patients, though it is not yet known how effective it is. It has been used in the official guidelines for treatment in China, South Korea and South Africa.

Chloroquine has been touted, prematurely, as a miracle cure, but, the report says, there has not been enough testing on its use to counter COVID-19. About 80 % of COVID-19 cases are mild, according to the World Health Organisation (WHO), with those patients recovering through resting at home without medical treatment or chloroquine, which, experts say, can interfere with the heart’s electrical activity.

Specialist physician and University of Witwatersrand infectious disease fellow Dr Jeremy Nel helped draw up the chloroquine treatment guidelines for South Africa. “The evidence for using chloroquine in COVID-19 is weak, although (human) studies at least have appeared promising,” Nel is quoted in the report as saying. “For hospitalised patients or those with risk factors for severe disease, we suggest considering a short course of chloroquine, pending further data.”

The US Food and Drug Administration has issued an emergency use authorisation for hydroxychloroquine and chloroquine for coronavirus treatment despite scant evidence. Politico reports that the agency allowed for the drugs to be "donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalised teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible."

US health authorities said that Sandoz donated 30m doses of hydroxychloroquine to the stockpile and Bayer donated 1m doses of chloroquine.

But, the report says, career scientists have been sceptical of the effort, noting the lack of data on the drugs' efficacy for coronavirus care and worried that it would siphon medication away from patients who need it for other conditions, calling instead for the agency to pursue its usual clinical trials.

FDA's move is expected to facilitate more access to the drugs by allowing more donations, and a second EUA is under consideration that would allow more manufacturers to produce it, said three officials.

"I would like to see who at FDA's (Medical Countermeasures Initiative) signed off on this EUA despite the total lack of scientific evidence that chloroquine/hydroxychloroquine are beneficial in the treatment of COVID-19," Luciana Borio, who served as FDA's acting chief scientist between 2015 and 2017 is quoted in the report as saying. "EUA is supposed to be issued when the evidence indicates that benefits outweigh the risks."

[link url="https://www.businesslive.co.za/fm/features/2020-03-27-sa-to-roll-out-chloroquine-to-tackle-coronavirus/"]Full Business Day report[/link]

[link url="https://www.politico.com/news/2020/03/29/fda-emergency-authorization-anti-malaria-drug-155095"]Full Politico report[/link]

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