Evansville clinical trial contributes to FDA authorization

Evansville clinical trial contributes to FDA authorization

EVANSVILLE, Ind. (WFIE) - Officials with Eli Lilly say 88,000 doses of its monoclonal antibody treatment have been shipped out to hospitals across the country. This comes after the FDA granted emergency use authorization on Monday.

One clinical trial in Evansville contributed to the final approval of the treatment from the FDA.

“It’s remarkable that so much data was collected in a small period of time," says Dr. David Schultz, the principal investigator of the clinical trial. "Evansville, Indiana had a small part to play in this.”

Dr. Schultz describes the authorization of Eli Lilly’s antibody treatment as tremendous.

“It’s gratifying professionally,” says Dr. Schultz, "because that’s what we are here to do. We are here to help others.”

He says the results from the clinical trial in Evansville were passed along to Eli Lilly and then presented to the FDA, along with other testing sites.

“The overall aim and hope is to speed up recovery," says Dr. Schultz, "but also to keep individuals from going down that path of where they become hospitalized and even worse.”

The hour-long IV infusion is designed for high-risk patients with mild to moderate symptoms. The infusion is followed by a few hours of monitoring, and then recipients are sent home.

“The monoclonal antibodies that are given,” says Dr. Schultz, "actually bind to the spike protein that is located on the coronaviral particles. In doing so, it makes it so when it’s trying to reproduce itself or replicate, it’s unable to do so. As a result the virus falls apart, and once it falls apart - it’s gone.”

While it’s not yet clear when and where the treatments will be shipped next, Dr. Schultz says the treatment puts us one step closer to defeating the virus.

Courtesy of Eli Lilly and Company
Courtesy of Eli Lilly and Company (Source: WFIE)

“We’ve been able to contribute to the international effort," says Schultz. "I think we have to take regional and local pride in knowing that. Absolutely, I couldn’t be more thrilled.”

Dr. Schultz added, in all the clinical trials, there were very few, mild symptoms, if any, among patients. Possible symptoms include flushing, dizziness, light-headedness, or anaphylaxis.

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