Cipla through a landmark agreement with Gilead Sciences Inc., was granted a license to manufacture and distribute the antiviral medicine, remdesivir, in 127 countries, including Kenya. As many of these emerging markets face obstacles in accessing healthcare, Cipla will expand supply to several Sub-Saharan African countries including KENYA.
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 hospitalized with COVID-193.
This authorization 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-193.
Remdesivir is also approved for emergency and compassionate use in India, Japan and Singapore on similar grounds4. 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 pandemic5.
CARING FOR LIFE
Commercial head of Cipla in Sub-Saharan Africa, Martin Sweeney, 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 make remdesivir available in Kenya at a significantly reduced price in comparison to other markets.
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 Pharmacy and Poisons Board(PPB)-approved production facilities.