(Reuters) –The U.S. Food and Drug Administration extended its review of Regeneron Pharmaceuticals Inc’s (NASDAQ:) application to approve its full COVID-19 anti-body therapy. The U.S drugmaker announced Thursday.

The health agency will review additional information submitted by Regeneron regarding the use of the antibody cocktail to preventive treatments before making a decision.

Regeneron announced that FDA does not require additional studies for its review. They will decide whether to approve the drug on July 13.

Regeneron’s “cocktail”, which consists of two monoclonal antibody combinations, imdevimab (casirivimab) and imdevimab (imdevimab), was granted an emergency authorization in the United States for treatment of COVID-19 patients aged 12 and over.

REGEN-COV was approved in the future for COVID-19 prevention in those who had been exposed to infected individuals or were high-risk of getting it.

Data showed REGEN-COV, a monoclonal antibody drug rival from Eli Lilly (NYSE :), were not likely to work against Omicron coronavirus variant. This led to the U.S. FDA revising the emergency use authorizations of both therapies to limit their usage.

Regeneron has partnered with Roche to develop and distribute the treatment in the United States.