Eli Lilly Seeks Emergency Use Approval for COVID-19 Antibody Drug

By Dana Cruz Oct 08 2020, 03:50 AM EDT

Eli Lilly's Antibody Treatment for COVID-19 Receives Emergency Approval From FDA — Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake/File Photo

Eli Lilly and Co applied for emergency use approval (EUA) for its experimental antibody drug on Wednesday.

The antibody drug reduced virus levels, hospitalizations, and emergency room visits of patients that exhibit mild to moderate cases of COVID-19, said Eli Lilly.

The data gathered by Eli Lilly right now is promising, and the company is planning to get another dual antibody drug approved next month as well.

According to The Wall Street Journal, this improvement could open new coronavirus treatments that can help early cases. Perhaps, these treatments can even prevent them.

Baird analyst Brian Skorney said the results from Lilly's study gave "some real evidence" that the monoclonal antibody approach provides clinical benefits.

Eli Lilly Reports No Adverse Effects

CNN reported that during its Phase 2 study, the antibody drug was received by 112 people, and 156 received a placebo.

Those who received a combination therapy had a statistically significant reduction in virus within three to seven days of their treatment. The company aimed to lower virus levels 11 days after treatment and met that goal during the drug's trial.

Eli Lilly said only 0.9 percent of the patients were hospitalized or sent to the emergency room. On the other hand, 5.8 percent placebo takers were sent to the hospital. These numbers point to a meaningful response of the human body to the treatment.

The therapy did not show any drug-related serious adverse effects as well. There were only "isolated drug-related infusion reactions or hypersensitivity," but the company assured that those were generally mild.

The data on the company's antibody therapies have not yet been published to a medical journal.

Manufacturing the Antibody Drug

Eli Lilly said the antibody drug, code named LY-CoV555, was derived from a blood sample of one of the earliest COVID-19 survivors.

The company added that they could manufacture 100,000 doses by the end of October. The firm is also hopeful of producing one million doses by the end of the year.

Eli Lilly is not the only drugmaker rushing to get a COVID-19 treatment out to the public. But none of them have yet to be given an EUA in the U.S.

Other therapies that received authorization as a COVID-19 treatment are Remdesivier of Gilead Sciences and convalescent plasma. Both targeted towards serious hospitalized cases. As such, Eli Lilly still seeks an EUA for treatments that they'll develop for higher-risk patients.

Professor Stephen Evans, of the London School of Hygiene and Tropical medicine told Science Medical Centre that while the data was "encouraging," it is still "preliminary."

"The evidence for their efficacy is encouraging but is still limited," he said.

Regeneron Pharmaceuticals developed an experimental dual-antibody cocktail, which was among the medicines received by President Donald Trump. The drug was supplied under the compassionate use program, said a Reuters report.

Eli Lilly did not distribute its drug through this program. It preferred to recruit patients in need of its clinical trials, said Chief Executive David Ricks. If Eli Lilly gets the EUA for its antibody treatment, the drug will be the first to treat less risky COVID-19 cases.