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.
PLEDGE TO FACILITATE ACCESS
Cipla has pledged to 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 to explore avenues of accelerated access to remdesivir.