Cipla through a landmark agreement with Gilead Sciences Inc.1, was granted a license to manufacture and distribute the antiviral medicine, remdesivir, in 127 countries, including Kenya2. 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 20203, 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.
1. Gilead website: Voluntary Licensing Agreements for Remdesivir. Available at https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir
2. Cipla website: Cipla enters into a licensing agreement With Gilead to expand access to COVID-19 treatment. Available at: https://www.cipla.com/press-releases-statements/cipla-enters-licensing-agreement-gilead-expand-access-covid-19-treatment
3. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment: Available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment
4. Reuters. Singapore approves remdesivir drug for emergency COVID-19 treatment. Available at: https://www.reuters.com/article/us-health-coronavirus-singapore-remdesiv/singapore-approves-remdesivir-drug-for-emergency-covid-19-treatment-idUSKBN23H17F
5. European Medicines Agency: First COVID-19 treatment recommended for EU authorization. Available at: https://www.ema.europa.eu/en/news/first-covid-19-treatment-recommended-eu-authorisation