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SAHPRA to facilitate controlled use of Ivermectin for COVID-19 patients

SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the progamme would be open to all patients, with the healthcare professional being responsible for the application and monitoring of the patient.

FILE: A health worker shows a box containing a bottle of Ivermectin, a medicine authorized by the National Institute for Food and Drug Surveillance (INVIMA) to treat patients with mild, asymptomatic or suspicious COVID-19, as part of a study of the Center for Paediatric Infectious Diseases Studies, in Cali, Colombia, on July 21, 2020. Picture: Luis Robayo/ AFP.

CAPE TOWN - The South African Health Products Regulatory Authority (SAHPRA) has announced it will facilitate a controlled, compassionate access programme for the use of Ivermectin.

The antiparasitic drug has gained popularity over recent weeks for its supposed benefits to treat COVID-19.

SAHPRA once again stressed there was not enough scientific evidence to enable a regulator to make a decision on the drug's use.

SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the progamme would be open to all patients, with the healthcare professional being responsible for the application and monitoring of the patient.

"This does not mean that our position changes around the lack of availability of scientific data. But we had to, as a regulator, have very in-depth discussions around the context we find ourselves in with the pandemic."

Semete-Makokotlela said they had anecdotal evidence of the current, illegal use of the drug on the black market.

"As we've indicated, we've seen widespread use and we've seen an emerging black market and we hope that this compassionate use will at least enable us to ensure that it is used adequately and we can get reporting on this product."

Board chairperson Professor Helen Reesc stressed the need for well-executed clinical trials to gauge the touted efficacy of the drug.

"Current data that's available to us and clinical trials are insufficient to give us convincing evidence of benefit in terms of efficacy. What we need are larger, better-designed trials that we all hope would give us a home run."

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