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Lilly seeks FDA emergency authorization for COVID-19 therapy

Riley Griffin

Eli Lilly & Co. asked U.S. drug regulators to authorize emergency use of its experimental COVID-19 antibody therapy after data showed the treatment reduced hospitalizations.

The Indianapolis-based pharmaceutical giant has approached the U.S. Food and Drug Administration for authorization of the treatment it’s developing with Canadian biotech AbCellera Biologics Inc., according to a statement Wednesday. It would allow high-risk patients recently diagnosed with mild-to-moderate COVID-19 to receive the therapy.

In this May 2020 photo provided by Eli Lilly, researchers prepare cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.

Antibody therapies from Lilly and Regeneron Pharmaceuticals Inc. are coming on the horizon to add to treatments doctors are using to treat COVID-19, which continues to spread around the world to millions of people. They are considered one of the most promising potential therapies for COVID-19, and have come into the spotlight after President Donald Trump received one being developed by Regeneron last week.

Lilly shares gained 3.4% to $149 in premarket trading in New York Wednesday. Through the close on Tuesday, the stock had risen 9.7% this year.

Lilly is also studying a cocktail of antibodies, and expects to approach regulators for authorization November based on additional data, and seek full approval for the combination therapy in the second quarter of 2021.

“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,” Daniel Skovronsky, Lilly’s chief scientific officer and the president of Lilly Research Laboratories, said in statement. “Lilly is diligently working with regulators around the world to make these treatments available.”

Monoclonal antibodies are artificial versions of proteins the immune system naturally makes to fight off infection. Regeneron and Lilly are seen as front-runners in a burgeoning development race to bring additional treatments for COVID-19 to market, particularly as the medical community increasingly suggests a vaccine may not serve as a silver bullet.

AstraZeneca Plc and GlaxoSmithKline Plc with its partner Vir Biotechnology Inc. also have products in development. Researchers believe the neutralizing antibody treatments also have the potential to work as preventive medication for those who may have been exposed to the virus.

Lilly and AbCellera’s experimental treatment, known as LY-Cov555, reduced the rate at which symptomatic patients were hospitalized or sent to the emergency compared to a placebo, according to interim study results released by the company. It also reduced patients’ viral load and other symptoms associated with the infectious disease.