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article imageHospitals to restrict COVID-19 antibody treatment limited supply

By Karen Graham     Nov 17, 2020 in Health
U.S. Hospitals, taking into account high demand and limited supplies, said they may limit the use of a new Eli Lilly antibody drug to COVID-19 patients with multiple risk factors or to those whose immune systems have not begun to fight the infection.
The monoclonal antibody treatment, bamlanivimab, was given U.S. emergency use authorization (EUA) last week by the Food and Drug Administration (FDA) for helping newly-diagnosed, high-risk patients avoid hospitalization.
The U.S. government agreed to pay Eli Lilly $375 million to supply 300,00 doses of the antibody treatment. The cost per dose of Lilly's treatment amounts to $1,250 as per the contract, however, patients will not have to pay for the medicine.
Also, on November 16, the Centers for Medicare & Medicaid Services *CMS)announced that Medicare beneficiaries can begin to receive coverage of monoclonal antibodies to treat coronavirus disease with no cost-sharing during the public health emergency (PHE).
And in a Tweet on November 13, Eli Lilly said: "Less than 12 hours after receiving emergency use authorization for our investigational #COVID19 antibody, the Lilly logistics team shipped the first doses, which reached patients just hours later."
The South Korean firm, Samsung BioLogics Co Ltd is mass-producing the COVID-19 antibody treatment developed by Eli Lilly. The plan is to manufacture up to one million doses by the end of 2020, for use worldwide through early next year. And it is expected that there will be a substantial increase in doses after the first quarter of 2021 as more manufacturing resources come online.
Samsung said that initially, they struggled to secure raw materials due to tight supplies. However, the company was able to expedite the technology transfer process, allowing it to begin shipments to Lilly five months after agreeing to a production deal in May.
It can take up to 90 days to manufacture a single batch of the active pharmaceutical ingredient and ...
It can take up to 90 days to manufacture a single batch of the active pharmaceutical ingredient and drug product for a neutralizing antibody for COVID-19. This is due to the highly complex manufacturing processes, with carefully controlled conditions and numerous quality and safety checks.
Eli Lilly and Company
Who gets the treatment?
When the FDA issued the EUA for Lilly's bamlanivimab - the authorization stated the drug was ti be used on patients over age 65 recently diagnosed with mild-to-moderate COVID-19 and patients with obesity, diabetes, or another risk factor. The FDA said the drug should not be used on hospitalized patients, according to Reuters.
The drug is being shipped to hospitals, initially, where a few are already set up to treat trial patients. Others are in the process of setting up treatment areas. But health officials are still deciding which patients would benefit most from the one-time infusion of the treatment, “Otherwise, we will be out of drug real soon,” said Dr. Howard Huang, a lung specialist at Houston Methodist.
“There may need to be some sort of composite score” to select patients, Huang said. “Maybe we would use it for someone who has cardiovascular disease, and a history of stroke and is older?”
"There will be a lot of pressure on physicians," said Dr. Adarsh Bhimraj, an infectious disease specialist at the Cleveland Clinic and chair of the Infectious Diseases Society of America's guidelines panel, which is still discussing its recommendations for the drug.
More about Eli Lilly antibody treatment, corid19, Emergency Use Authorization, 300K doses, One Week
 
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