The Emergency Use Authorization (EUA) for remdesivir was first issued by the United States Food and Drug Administration (FDA) on 1 May 2020, mainly based upon a study funded by the National Institute of Allergy and Infectious Diseases (NIAID) in the USA. This study showed that remdesivir shortened the time to recovery in patients hospitalised with Covid-19.
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 view that the known and potential benefits of remdesivir outweigh the known and potential risks, and 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 25 June 2020, remdesivir was recommended for a conditional marketing authorisation by the European Medicines Agency, a regulatory mechanism to facilitate early access to medicines that fulfil an unmet medical need, including in emergency situations in response to public health threats such as the current Covid-19 pandemic.
Caring for life
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 much the same way as Cipla pioneered affordable medication during the height of the HIV crisis about two decades ago and helped to save the lives of millions of people, we're committed to help find a solution in the fight against this unprecedented global pandemic."
Cipla will, therefore, ensure that the price of its remdesivir will be less than or similar to prices offered in other emerging markets, facilitating access to this medicine. Cipla commenced manufacturing of remdesivir last week on a dedicated line at one of its FDA-, WHO- and SAHPRA-approved production facilities.
Furthermore, Cipla will continue to engage with the South African Health Products Regulatory Authority ("SAHPRA") to explore avenues of accelerated access to remdesivir.