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Remdesivir Approved by the FDA to Treat COVID-19

11 May 2020

COVID-19, which is caused by SARS CoV2 and commonly referred to as “coronavirus”, has claimed the lives of over 200,000 people within a few months. Following an unprecedented and ongoing effort from the pharmaceutical industry, on May 1st 2020, the USA Food and Drug Administration (FDA) approved the antiviral pro-nucleotide drug (ProTide) Remdesivir, developed by Gilead Sciences Inc., as treatment for COVID19.

ProTide delivery technology was pioneered at Cardiff University School of Pharmacy and Pharmaceutical Sciences by Prof. Chris McGuigan (1958-2016) and has been shown to dramatically improve the therapeutic activity of antiviral nucleoside drugs. Indeed, Remdesivir is the third antiviral ProTide to be approved by the FDA after sofosbuvir and tenofovir alafenamide.

Remdesivir, formerly known as GS-5734, was initially developed and studied in patients to treat Ebola. However, in 2018, this experimental medicine showed excellent activity against coronaviruses including those that cause MERS and SARS infections. Therefore, when the COVID19 outbreak began in China at the end of 2019, Remdesivir emerged as a potential treatment for this new viral infection. Indeed, a series of studies in animals and humans showed the promise of Remdesivir in managing COVID19. In particular, the ability of Remdesivir to speed up the recovery of COVID19 patients was noted as being significant, and this ultimately led to its approval as a treatment for the disease. In a gesture of goodwill, and due to the severity of the pandemic, Gilead Sciences have donated 1.5 million vials of the drug to the American government.

Additionally, a series of anticancer ProTide prodrugs discovered at Cardiff University by the same team - now being led by Drs Michaela Serpi and Magdalena Slusarczyk - are currently undergoing clinical trials in collaboration with NuCana plc. Cancer ProTides in clinical development include Acelarin (Phase III, pancreatic and biliary tract cancer), NUC-3373 (Phase Ib, metastatic colorectal cancer) and NUC-7738 (which has shown to have anti-cancer activity across a range of cancers).

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