In a breakthrough agreement with US-based bio-pharmaceutical company Gilead Sciences, Cipla South Africa, the country’s third largest pharmaceutical manufacturer, has been granted a license to manufacture and distribute the antiviral medicine remdesivir for South Africa and 126 other sub-Saharan countries.
The Emergency Use Authorization (EUA) for remdesivir was first issued by the United States Food and Drug Administration (FDA) on 1 May 2020. Based on a study funded by the National Institute of Allergy and Infectious Diseases (NIAID) in the USA, it was found that remdesivir shortened the recovery time of patients hospitalised with Covid-19. According to NIAID, patients with advanced Covid-19 and lung involvement, who received remdesivir, recovered 31 percent faster and had better survival rates than those treated with a placebo.
This authorisation for emergency use was granted by the FDA on the basis that SARS-CoV-2 can cause a serious or life-threatening disease or condition. Their decision took into account that the known and potential benefits of remdesivir outweigh the known and potential risks, in addition to the fact that there is currently no adequate approved alternative treatment available for Covid-19
Remdesivir is also approved for emergency and compassionate use in India, Japan and Singapore, on similar grounds. More recently, on June 25 2020, remdesivir was recommended for a conditional marketing authorisation by the European Medicines Agency, a regulatory mechanism to facilitate early access to medicines that fulfill an unmet medical need, including in emergency situations in response to public health threats such as the current Covid-19 pandemic.
CEO of Cipla South Africa, Paul Miller, says: “As part of our ethos of Caring for Life, Cipla always aims to ensure that everyone has access to life-saving medication. In the same way the Cipla pioneered affordable medication during the height of the HIV crisis two decades ago and helped save the lives of millions of people, we are committed to help find a solution in the fight against this unprecedented global pandemic.
We are yet to see the impact this drug will have on Covid-19 rates when it lands in South Africa – yet, the concept of a potential treatment is a step in the right direction.
