PITTSBURGH (KDKA) — Drugmaker Eli Lilly is requesting emergency use authorization for its antibody treatment for coronavirus.
“We’re in a situation where we don’t have effective treatments or current treatments are limited,” says AHN Emergency Medicine physician Dr. Arvind Venkat.
Based on blood from an early American survivor of COVID-19, the product is a manufactured antibody that mimics the body’s own immune response and neutralizes the virus.
“The technology behind this is not new. Antibodies are part of our immune response,” says Dr. Venkat. “The idea here is to develop an antibody that is specific to COVID-19 and to give it to patients who are ill to bolster their immune response.”
The authorization would be for high-risk patients with mild to moderate illness.
“The elderly, especially elderly males and especially those who have underlying medical conditions — such as obesity or diabetes or other underlying lung conditions or heart conditions,” Dr. Venkat said. “Mild to moderate would probably be they either don’t have an oxygen requirement, or they don’t have a significant oxygen requirement.”
The company says the phase 2 trials show decreased hospitalization for the people who received it — 1.6 percent compared to 5.8 percent of the placebo group.
“A phase 2 trial by definition is very small,” said Dr. Venkat. “We need to take it with a grain of salt until we have a much larger number of patients in a phase 3 clinical trial and followed for a long enough period of time to make sure the medication is both safe and effective. The history of medicine and history of clinical research is riddled with examples of medications and treatments that work great in phase 1 and phase 2 trials, and then were not borne out in phase 3 trials and didn’t make it into the day-to-day treatments that we can patients.”
Whether Dr. Venkat would prescribe it himself?
“I will want to read the data and the basis for the emergency use authorization. And I will need to weigh that against the risk to my patients,” he says. “It’s not meant for, let’s just use it as if it’s actually proven to be safe and effective. It’s for very narrow circumstances. I expect it will become part of the tools we have in the emergency department. I don’t think it will be used widely.”
This antibody treatment is a competitor of Regeneron’s, which the president received. Regeneron is also seeking emergency use authorization for its antibody cocktail.
If the FDA grants emergency use authorization, 100,000 doses could be available later in October. This would be the first available drug option for treating less severe cases of COVID-19.