Ivermectin gets the greenlight from SAHPRA, but with limits

Picture: Pixabay.com

South African Health Products Regulatory Authority (SAHPRA) has decided to approve the drug ivermectin for the treatment of the Covid-19 virus. 

“We have listened and we have heard”, these are the words of SAHPRA CEO Dr Boitumelo Semete-Makokotlela.

On the 6th of January, the regulator denied the approval of the drug for human use in the country. They said that they would continue to review emerging data on the product, but at the time the scientific data required to justify the approval of the drug for human use was not sufficient.

Dr Semete-Makokotlela said that since the previous briefing extensive pieces of data has emerged:

  • SAHPRA has engaged with the World Health Organisation (WHO) who in their statement about the use of ivermectin for the treatment of Covid-19 stated that the product had limited data and ongoing clinical trials would be reviewed to gather sufficient data. 
  • The SAHPRA team also engaged with other regulators they work closely with, such as the Food and Drug Administration (FDA), European Medicine Agency, the MHRA (The Medicines and Healthcare products Regulatory Agency) in the UK, who all have a similar stance on the use of the drug. 
  • Recent data as a follow-on from Dr. Andrew Hill’s presentation has also emerged and been reviewed.

VK news reported on Dr Naseeba Kathrada and many other doctors’ pleas to legalise the use of ivermectin.

Semete-Makokotlela said that the regulator fully understood and appreciated the strife of the healthcare practitioners fighting the pandemic on the frontlines. The frustration and desperation behind the limited options for the prevention and cure of the Covid-19 virus.

SAHPRA will allow for the use of the drug after deep discussions with key role players and medical professionals. The regulator said that they will work closely with medical practitioners who will be responsible for reporting on the side effects both negative and positive to develop a longer-term access protocol.

The drug will only be allowed under a controlled and compassionate access programme and details will be released within the next few days.