Eli Lilly Files Emergency Use Application With FDA for COVID Antibody Treatment; Shares Leap

Eli Lilly said its developmental antibody treatment "may be effective to treat COVID-19 in patients with a high risk for serious outcomes" and has sought approval for its emergency use with the FDA.

Eli Lilly & Co. LLY said Wednesday that it has submitted an application with the U.S. Food & Drug Administration for the emergency use of its coronavirus antibody treatment.

Eli Lilly said the request for Emergency Use Authorization, or EUA, followed trial data showing that the experimental antibody, Y-CoV555, met both primary and secondary endpoints. The drugmaker had earlier noted the that the treatment reduced the need for hospitalization and emergency-room visits among patients with moderate coronavirus symptoms.

"Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments," said Eli Lily's chief scientific officer Daniel Skovronsky. "We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. 

"Lilly is diligently working with regulators around the world to make these treatment available," he added.

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Eli Lilly shares were marked 3.77% higher in early trading Wednesday to change hands at $149.44. each, a move that pushes the stock's six-month gain to around 5%.

Earlier this month, Eli reached an agreement with Amgen  (AMGN) - Get Amgen Inc. Report to manufacture its potential coronavirus antibody treatment as global cases now look set to pass the 35 million mark.

Eli Lilly said it's studying several neutralizing antibodes for the prevention and treatment of COVID-19, either in combination with other drugs or as a so-called monotherapy, adding that its collaboration with Amgen would "significantly increase the supply capacity" of any potential treatment breakthrough. 

Earlier this summer, Eli Lilly started providing patients with doses of its potential coronavirus treatment in what it said was the world's first study of a potential antibody to the global disease.

Lilly said its LY-CoV555 treatment, which could create antibody therapies for the prevention and treatment of COVID-19, was given to patients as part of early stage trials at the NYU Grossman School of Medicine in New York and Cedars-Sinai Medical Center in Los Angeles.