When Could Regeneron Antibody Become Available to Public?

Regeneron Pharmaceuticals has applied for Emergency Use Authorization (EUA) of its monoclonal antibody drug, REGN-COV2. According to CNN, it's the first potential treatment that uses two antibodies instead of one to fight the virus. President Donald Trump was treated with the antibody cocktail when he recently fell ill with COVID-19, but it is not yet approved for use in the general public. The fast-tracking EUA could make it available soon, say experts.

According to USA Today, the company still has to prove its product is safe and effective and must go through testing. An EUA is granted in times of emergency, such as the current pandemic and if "there are no adequate, approved and available alternatives," according to the Food and Drug Administration (FDA).

A regular application process would require Regeneron to prove its pharmaceutical "is determined to provide benefits that outweigh its known and potential risks." According to the FDA, a drug given priority status can be approved within six months versus 10 months for a standard review. An EUA may be even faster than a priority review, according to USA Today, and the FDA is working overtime to process new drugs and treatments for COVID-19.

On Thursday, the Infectious Diseases Society of America issued a statement asking that the FDA "continue to base any approval, including Emergency Use Authorization of treatments and vaccines, on established scientific standards." The society warned that drug approval based on limited data "can put patients at risk of adverse events," and it urged the FDA "to apply its highest standards on the EUA application filed by Regeneron."

According to USA Today, if Regeneron receives EUA, it would be limited and would expire when the emergency ends. The company would then have to reapply though normal licensing procedures.