Authorization of the drug addresses a hole in Covid-19 treatment, providing options for the infected before they require hospitalization
U.S. health officials on Monday authorized use of the first treatment for people with earlier-stage Covid-19 who aren’t hospitalized, filling a gap in treatment.
The U.S. Food and Drug Administration said Eli Lilly LLY -0.29% & Co.’s antibody drug should be used for patients ages 12 and up with mild to moderate Covid-19, based on a study showing it helped improve symptoms and kept many patients out of the hospital.
The FDA said the drug is authorized for patients at high risk of progressing to severe Covid-19, including people 65 and older, or who have certain chronic medical conditions. The drug shouldn’t be given to hospitalized patients, the FDA said, because it showed no clinical benefit in a study among such patients.
The drug’s authorization “provides health care professionals on the frontline of this pandemic with another potential tool in treating Covid-19 patients,” said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research.
The drug is named bamlanivimab. Lilly said it will begin shipping the drug immediately to AmerisourceBergen Corp. ABC 2.22% , a national drug distributor, to distribute it as directed by a federal allocation program.
The drug will be “a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said Lilly Chief Executive David Ricks.
Regeneron Pharmaceuticals Inc. REGN -1.81% also has requested FDA authorization of its own antibody-based therapy for Covid-19. “We continue productive discussions with the FDA regarding our EUA submission,” Regeneron said.
The drugs are part of a class of medicines known as monoclonal antibodies that are designed in labs to mimic the naturally occurring antibodies that the immune system produces to fight off viruses and other foreign invaders.
The Covid-19 antibodies were derived from antibodies isolated in the blood of people who recovered from the disease and, in Regeneron’s case, from genetically modified mice.
The class garnered lots of attention after President Trump was given Regeneron’s antibody drug and then attributed his return to health to the therapy, though doctors cautioned against singling out one factor.
“They gave me Regeneron, and it was like, unbelievable. I felt good immediately,” Mr. Trump said in October.
The drugs so far have shown the greatest effectiveness in treating patients early in the course of disease with mild or moderate symptoms. Most of those patients tend to clear the virus on their own regardless of whether they receive treatment, which could make it difficult for doctors to determine who should receive the relatively expensive and scarce doses of the drugs.
Of 309 study subjects injected with Eli Lilly’s drug, five, or 1.6%, were later hospitalized or visited the emergency room, compared with nine of 143 people who received a placebo, or 6.3%. Lilly also said patients receiving the drug had more rapid improvement in symptoms compared with those who received a placebo.
So far, only a few drugs have been shown to work against Covid-19 and only in hospitalized patients, including Gilead Sciences Inc.’s GILD -0.03% remdesivir. The new antibodies from Lilly and Regeneron can be used before patients become severely ill.
Lilly’s is the first authorized drug specifically designed this year to fight Covid-19. Gilead’s remdesivir, for example, was originally designed to treat other viruses and was subsequently found to be effective for Covid-19.
The Covid-19 antibody drugs also have the potential to prevent disease in people at risk of infection. Lilly is testing its drug in the staff and residents of nursing homes if a Covid-19 case had been identified at a facility.
The FDA’s clearance of the drug is technically known as an emergency-use authorization, which the agency uses in public-health emergencies to greenlight a drug more quickly than a standard approval.
The federal government has agreed to buy hundreds of thousands of doses of Lilly’s and Regeneron’s drugs, and will be in charge of allocating supply to states, which will in turn determine which hospitals and health facilities should get them.
The drugs are administered via intravenous infusion, requiring patients to go to a hospital outpatient clinic or standalone infusion clinic.
The government-purchased doses will be allocated to states and U.S. territories based on their share of hospitalized and infected patients, a spokeswoman for the Department of Health and Human Services said.
The drug will be provided for free, but doctors can charge insurers for the cost of administering the drug, the spokeswoman said.
Lilly originally code-named its drug LY-CoV555 but is now calling it bamlanivimab. The company developed it in collaboration with AbCellera Biologics Inc., of Vancouver, British Columbia, which isolated antibodies from a blood sample taken from one of the first Americans to recover from Covid-19. AbCellera also collaborated with the National Institute of Allergy and Infectious Diseases on discovering the antibody.
In late October, Lilly signed an agreement to provide 300,000 doses of the antibody to the federal government for $375 million. Lilly said each vial, which is enough to treat one patient, will cost $1,250. Lilly said it expects to have 100,000 doses ready to ship within days of authorization, and expects to have up to one million doses by the end of the year.