FDA on Monday issued an emergency use authorization (EUA) that allows providers to use Eli Lilly's experimental antibody therapy, bamlanivimab, to treat patients ages 12 and older with mild-to-moderate cases of Covid-19 who haven't been hospitalized, but who have high risk for hospitalization.
US new coronavirus cases near 10.2M, deaths approach 239K, hospitalizations top 59K
The EUA comes amid a continuing surge in new coronavirus cases and hospitalizations in the United States. On Monday, the United States reported 130,553 new cases of the novel coronavirus, according to data compiled by the New York Times, marking the seventh day in a row that the country reported more than 100,000 new cases of the novel coronavirus in a single day.
Overall, as of Tuesday morning, U.S. officials reported a total of about 10,191,200 cases of the novel coronavirus since America's epidemic began, up from about 10,060,700 cases reported as of Monday morning.
According to the Times, the United States' average daily number of newly reported coronavirus cases over the past week was 116,448—which is up by 64% when compared with the average from two weeks ago.
As of Tuesday morning, data from the Times showed that the rates of newly reported coronavirus cases were "staying high" in Guam, Puerto Rico, and 45 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
The U.S. Virgin Islands; Washington, D.C.; and five states that have had comparatively low case rates were seeing those rates "going up" as of Tuesday morning, according to the Times. Those states are California, Hawaii, Maine, New Hampshire, and Vermont.
As cases numbers climb, hospitalizations for Covid-19, the disease caused by the novel coronavirus, also are rising. According to data from The Atlantic's Covid Tracking Project, 59,275 Americans were hospitalized for Covid-19 as of Monday. That number had climbed by 14% over the previous seven days and is nearing the United Sates' record number of nearly 60,000 Covid-19 hospitalizations, which the country reported during the summer, NPR's "Shots" reports.
The number of reported deaths tied to the novel coronavirus also is rising at a quicker pace, with the United States last week reporting more than 1,000 new deaths tied to the virus for four consecutive days for the first time since August. As of Tuesday morning, U.S. officials had reported a total of about 238,700 U.S. deaths linked to the virus since the country's epidemic began, up from about 238,031 deaths reported as of Monday morning.
FDA issues EUA for Eli Lilly's experimental antibody therapy
On Monday, FDA granted an EUA that "allows for [Eli Lilly's] bamlanivimab to be distributed and administered as a single dose intravenously by health care providers."
Specifically, the EUA authorizes the treatment for patients ages 12 and older with mild-to-moderate cases of Covid-19 who haven't been hospitalized, but who are at risk of severe illness or hospitalization—including patients who are older than 65, are obese, and/or display other risk factors. According to Eli Lilly, the antibody therapy should be administered as soon as possible after a patient receives a positive coronavirus test, and within 10 days of patients developing Covid-19 symptoms.
However, FDA stated that bamlanivimab is not authorized to treat Covid-19 patients who have been hospitalized or who require oxygen because the therapy has not shown a benefit in hospitalized Covid-19 patients. "Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation," FDA said.
The EUA comes after President Trump credited an experimental antibody treatment developed by Regeneron for his Covid-19 recovery—and called on FDA to issue EUAs for Regeneron's and Eli Lilly's experimental antibody therapies.
The data supporting FDA's decision
FDA issued the EUA based on an interim analysis of data from a randomized, double-blind, placebo-controlled Phase 2 clinical trial involving 465 adults with mild to moderate cases of Covid-19 who had not been hospitalized. For the trial, researchers gave a 700-milligram dose of bamlanivimab to 101 patients; a 2,800-milligram dose of bamlanivimab to 107 patients; a 7,000-milligram dose of bamlanivimab to 101 patients; and a placebo to 156 patients. All doses were administered within three days of a positive coronavirus test result.
According to FDA, the interim analysis of the trial data showed most of the patients, including those who received a placebo, cleared the virus within 11 days.
However, FDA said "the most important evidence that bamlanivimab may be effective" against the coronavirus came from data focused on Covid-19-related hospitalizations and ED visits within 28 days after treatment. On average, the researchers found hospitalizations and ED visits occurred in 3% of patients treated with bamlanivimab, compared with 10% of patients who received a placebo.
According to FDA, the researchers found similar effects on viral load, hospitalizations, ED visits, and safety among the patients who received different doses of bamlanivimab.
CMS spokesperson says HHS will distribute and Medicare will cover antibody therapies to hospitals
A CMS spokesperson told Becker's Hospital Review that HHS will purchase and distribute antibody therapies authorized by FDA, and CMS will cover the costs of administering the treatments for Medicare beneficiaries.
According to the spokesperson, HHS will buy initial doses of the antibody treatments and then distribute them to hospitals at no cost. HHS plans to distribute the treatments using data on the numbers of confirmed coronavirus cases in states and U.S. territories, which is the same method it used to distribute remdesivir.
HHS will allocate a share of the $100 billion in funds available under the Provider Relief Fund to reimburse hospitals at Medicare rates for providing treatments related to Covid-19 to uninsured patients, the spokesperson said.
According to the spokesperson, CMS will issue billing codes soon after FDA authorizes antibody therapies to allow hospitals to charge Medicare for the treatments they purchased for beneficiaries.
Regarding Eli Lilly's treatment specifically, the company in October announced that it had forged a deal to sell 300,000 doses of the therapy to the federal government. According to the Times, the company will start shipping the therapy to AmerisourceBergen, which will distribute it with assistance from the federal government. The federal government, under the agreement, will oversee decisions about how to allocate the therapy (Wall Street Journal, 11/10; Thomas/Weiland, New York Times, 11/9; Wang/Lienhard, Inside Health Policy, 11/9 [subscription required]; Johnson, Washington Post, 11/9; Edwards, NBC News, 11/9; FDA release, 11/9; Anderson, Becker's Hospital Review, 11/9; New York Times, 11/10).