March 18, 2020

COVID-19 and Clinical Trials

Many clinical trials are underway for drugs to combat COVID-19, but the FDA gave special notice to two drugs.

Gilead Sciences initiated two Phase 3 studies of the investigational antiviral remdesivir for treatment of COVID-19, while Regeneron and Sanofi began concurrent Phase 2 and 3 clinical trials for utilizing sarilumab (Kevzara) in COVID-19 patients to reduce overactive inflammatory response in the lungs.

However, the FDA is alerting the public that due to disruptions to business operations from COVID-19, clinical trials for new drugs in development may be delayed. In response to this, the FDA introduced guidance documents to help developers navigate these items, but it is likely that many drugs in development will face delays.

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