The U.S. Food and Drug Administration (F.D.A.) on Monday issued an emergency use authorization for Eli Lilly and Company's (NYSE: LLY) monoclonal antibody therapy bamlanivimab for mild to moderate coronavirus infections present in patients 12 year old or older that do not require hospitalization. The treatment is administered once intravenously through an IV.
While the therapy is still undergoing additional clinical testing to figure out its safety and effectiveness profile, early trial results show that the drug may help clear coronavirus infection sooner and potentially shorten or prevent hospitalizations for patients with mild to moderate infections. A previous study of the drug in hospitalized patients was halted by independent monitors, with the drug appearing to offer no real benefits.
Lilly's drug is a biologic therapy that consists of laboratory-grown antibodies that are designed block the SARS-CoV-2 virus' attachment and entry into healthy human cells. Bamlanivimab is a concentrated version of the Lilly-developed antibodies that proved to be most effective against the coronavirus in early clinical studies.
Similar therapies exist against the novel coronavirus, like Regeneron Pharmaceuticals' (NASDAQ: REGN) antibody therapy that was most notably given to President Donald Trump for the treatment of his coronavirus infection back in October. Regeneron is also seeking an emergency use authorization from the F.D.A.
The U.S. government has already signed an agreement with Lilly to buy 300,000 vials of the drug for $375 million, although it is unclear at this time how many doses of the drug that amount will provide. Experts are hoping that antibody therapies will be one of the ways healthcare systems can manage the virus until effective vaccines are widely available.
Yet, the drug is still facing logistical challenges on how the drug will be administered to the broader public. The therapy is designed to be given to patients through an IV infusion that last over an hour and requires another period of observation by a healthcare provider afterward, U.S. senior administration officials warned reporters on Tuesday, reported by CNBC. That means that healthcare providers must have appropriate staffing, training and equipment to facilitate the demand for the intravenous drug.
According to Dr. Janet Woodcock, director of the F.D.A.'s Center for Drug Evaluation and Research, the Trump administration is currently developing plans that will help states with these challenges, CNBC reports.
Health and Human Services Secretary Alex Azar stated on Tuesday that the U.S. government will begin distribution of Lilly's drug this week through Operation Warp Speed.
"We have a contract to purchase 300,000 doses of this product through December with the option to purchase another 650,000 doses through next June as well," Azar stated. "There are over 80,000 doses available for allocation and distribution this week, and we'll be working with state, local and territorial health department so that patients can receive the infusion in hospitals, outpatient clinics or alternative care settings."
The amount of drug distributed across the U.S. will be based on the states' share of the country's total number of confirmed coronavirus patients and total number of hospitalized patients in a given week, Azar stated. The drug will be distributed in two phases, with hospitals and hospital-affiliated facilities receiving the first doses, and outpatient centers receiving the rest.
Currently, Gilead Sciences' (NASDAQ: GILD) remdesivir is the only drug that is fully approved by the F.D.A. to treat the coronavirus. The U.S. government also recommends the use of steroids like dexamethasone to treat severely ill patients in hospital settings. The F.D.A. has also given an emergency use authorization to the use of convalescent plasma, but no large studies have shown this treatment to be more effective than standard care at this time.