‘There is no significant evidence of clinical efficacy in patients with Covid-19’ – ivermectin manufacturer



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    An overview of the drug Ivermectin.

An overview of the drug Ivermectin.

(Photo by Gallo Images / Ziyaad Douglas)

  • The original manufacturer of ivermectin, Merck, has said that there is not enough evidence to support its use in treating Covid-19 patients.
  • The company said it had found “no scientific basis” for its use against Covid-19 after studying various findings from emerging studies.
  • Ivermectin use is allowed in South Africa only upon request to the Health Products Regulatory Authority of South Africa.

Merck, the original manufacturer of ivermectin, has said that there is insufficient data available to support the use of the drug in patients with Covid-19.

Known as MSD outside of the United States and Canada, the company said its scientists continue to carefully examine the findings of all available and emerging studies of ivermectin for the treatment of Covid-19 in search of evidence of efficacy and safety.

READ | Ivermectin for use in urgent cases of Covid-19 allowed before Section 21 applications are approved

However, the company scientists have found “no scientific basis for a potential therapeutic effect against Covid-19 from preclinical studies” and “no significant evidence of clinical activity or clinical efficacy in patients with Covid-19 disease.” .

“We do not believe that the available data support the safety and efficacy of ivermectin beyond the doses and populations indicated in the prescribing information approved by the regulatory agency,” the company said in a statement published Thursday.

Ivermectin, a parasiticide, has received attention as a possible Covid-19 treatment, Health24 reported.

The Health Products Regulatory Authority of South Africa (Sahpra) initially announced that it will allow the use of the drug in exceptional circumstances, in a compassionate and controlled access program through the use of a Section 21 application. In terms of the Health Control Act Medicines and Related Substances, a Section 21 application is the process used to request the prescription of non-registered medicines for human use in South Africa.

Sahpra has been hesitant to allow the use of ivermectin for the treatment of Covid-19, saying there was not enough clinical evidence to support its use.

However, on Tuesday a tentative agreement was reached in Gauteng High Court between Sahpra, AfriForum and others to allow doctors, in cases deemed urgent, to start ivermectin treatment as soon as a request from the Section has been submitted. 21, without having to wait for the result of the request.

According to the World Health Organization, Merck’s patent for ivermectin expired in 1996, allowing other companies to produce ivermectin thereafter.

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