Home News SA company granted licence to produce Covid-19 approved US-developed drug

SA company granted licence to produce Covid-19 approved US-developed drug

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According to NIAID, hospitalised patients with advanced Covid-19 and lung involvement who received remdesivir recovered 31 percent faster.

Remdesivir can help with Coronavirus disease. Picture: Reuters
Cipla South Africa is gearing up to produce Covid-19-approved US-developed drug remdesivir for South Africa and several other sub-Saharan countries.

Through a landmark agreement with Gilead Sciences, Cipla has been granted a license to manufacture and distribute the antiviral medicine in 127 countries, including South Africa.

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 hospitalised with Covid-19.

According to NIAID, hospitalised patients with advanced Covid-19 and lung involvement who received remdesivir recovered 31 percent faster and had better survival than those treated with a placebo

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 June 25 2020, remdesivir was recommended for a conditional marketing authorisation by the European Medicines Agency, a regulatory mechanism to facilitate early access to medicines that fulfill an unmet medical need, including in emergency situations in response to public health threats such as the current Covid-19 pandemic5.

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.”