Will REGN-COV get an emergency use approval?

REGN-COV is a combination of two monoclonal antibodies that work in reducing the infectivity of COVID-19. Until this movement the FDA didn’t approve the use of REGN-COV on COVID-19 patients, despite that, President Donald Trump had the luxury to try the medication and to describe it as a cure for COVID-19.

The new news post the usage of the medication outside a clinical trial encouraged Regeneron to ask the FDA to approve REGN-COV under the emergency use approval (EUA) category for COVID-19 patients. In case this approval was granted, Regeneron expected to supply treatment up to 300,000 patients by next month. Additionally, Regeneron agreed with Roche, to distribute REGN-COV globally outside the US market.

Currently, there are several ongoing clinical trials for REGN-COV:

1. Phase 1: ARS-CoV-2 Virus Multi-Antibody Therapy Multi-dose Phase 1 safety study in healthy volunteers
2. Phase 2: SARS-CoV-2 Virus Multi-Antibody Therapy Treatment for hospitalized and non-hospitalized patients with COVID-19
3. Phase 3:  SARS-CoV-2 Virus Multi-Antibody Therapy Prevention of COVID-19 in household contacts of diagnosed patients

The biotech company’s said: “If a EUA is granted, the government has committed to making these doses available to the American people at no cost ”