Cipla has been granted a license by Gilead Sciences to manufacture and distribute the antiviral medicine, remdesivir, in 127 countries, including South Africa,
As many of these countries are low-income countries and emerging markets that face obstacles in accessing healthcare, Cipla will expand supply to several sub-Saharan African countries.
The Emergency Use Authorisation (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. The study showed that remdesivir shortened the time to recovery in patients hospitalized with Covid-19.
The 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.
Paul Miller, CEO of Cipla South Africa, 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.”
In light of this, Cipla will 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.
The company started manufacturing of remdesivir last week on a dedicated line at one of its FDA-, WHO- and SAHPRA-approved production facilities.
Cipla states that it will continue to engage with the South African Health Products Regulatory Authority (SAHPRA) to explore avenues of accelerated access to remdesivir.