Eli Lilly's Antibody Treatment for COVID-19 Receives Emergency Approval From FDA

Eli Lilly and Co's monoclonal antibody therapy received emergency use authorization from the U.S. Food and Drug Administration (FDA) on Monday.

The FDA approved Eli Lilly's antibody treatment called bamlanivimab only for moderate coronavirus infections in adults and children.

Eli Lilly noted that their treatment should be given as soon as possible after a positive coronavirus test and within 10 days of developing symptoms.

The FDA said it should not be given to hospitalized patients and has to be infused in a healthcare setting.

The antibody treatment can be given to 12 and older people and are at risk of developing severe COVID-19 or hospitalized for the condition. That will include people with underlying health conditions like diabetes, sickle cell disease, chronic kidney disease, and obesity, or anyone over 65 years old, said NBC News.

Bamlanivimab is First FDA-Approved Antibody Treatment

Bamlanivimab is the first monoclonal antibody to receive FDA authorization for treating coronavirus, noted CNN.

The approval vastly expands the usage of Eli Lilly's monoclonal antibody treatment, which was first limited to clinical trials only.

It provides healthcare workers with "another potential tool in treating Covid-19 patients," said Dr. Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research.

"It's a great day for science and medicine - sort of a feat of what's possible," Dr. Daniel M. Skovronsky, the chief scientific officer of Eli Lilly told New York Times.

As Skovronsky pointed out, the company was able to create a new drug, manufacture it, test it, and get a nod from the FDA in only seven months.

The company applied for emergency use clearance in early October after the company found promising trial data.

The firm's research suggested that the therapy could help keep COVID-19 from progressing to where patients will have to be hospitalized.

Antibody Treatment Kick-Starts Immune Response

The idea behind antibody treatment is to trigger an immune response that could fight off infection.

According to a FDA statement, these kinds of treatment are laboratory-made proteins that mimic the immune system's ability to fight harmful antigens like viruses.

Bamlanivimab was made specifically to target the spike protein of SARS-CoV-2. It will block the virus' attachment and entry into human cells, explained the FDA.

The treatment is similar to the one received by President Donald Trump when he was hospitalized for COVID-19. However, the emergency use authorization does not apply to patients who need help breathing.

In fact, in an earlier story by Latin Post, the treatment was reported ineffective for these kinds of COVID-19 cases.

There is a chance for such patients to do worse with the antibody treatment if they need high-flow oxygen or mechanical ventilation.

FDA's approval was based on the study published in the New England Journal of Medicine in October.

It found that bamlanivimab lowered the risk of hospitalization and eased symptoms in a small number of patients who experience mild to moderate COVID-19.

Eli Lilly's Phase 2 trials involved 452 patients. Some of them received the treatment, and others received a placebo.