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The federal government will begin dispensing doses of Regeneron’s antibody drug therapy against COVID-19 on Tuesday, senior health officials said.
In a call with reporters, Health and Human Services (HHS) Secretary Alex Azar said the administration would distribute 30,000 doses of the drug, with more to come in the coming weeks.
The company plans to produce 300,000 doses by early January.
In July, the Trump administration’s Operation Warp Speed gave Regeneron $ 450 million to support manufacturing of the drug.
Allocations limited to state and territorial health services will be proportionately based on confirmed cases of COVID-19 in the previous seven-day period. The information is based on data that state hospitals and health departments submit to the HHS COVID-19 response data center.
Officials said the drug will be distributed in two phases due to difficulties in delivering the drug, which must be administered intravenously over an hour.
Patients must then be monitored for an hour after the infusion, which could be problematic for health systems already experiencing a COVID-19 outbreak.
Ambulatory infusion centers may be the best places to administer the drug, but facilities may not have the appropriate equipment, staff training, or infection control practices to treat patients with COVID-19 when ‘they are the most infectious. The phased approach will give facilities time to prepare, officials said.
Initially, states and territories will allocate proceeds only to hospitals and hospital facilities. The second phase will include expanded distribution to other outpatient facilities.
While the federal government will allocate the drug to state and territory departments of health, those departments of health will be responsible for distributing treatment to facilities in their respective states and territories.
The Food and Drug Administration (FDA) on Saturday granted emergency clearance for the treatment. The drug combines two monoclonal antibodies, which are laboratory-produced versions of one of the main defenses of the human body against pathogens.
The drug is authorized for the treatment of mild to moderate COVID-19 in adults and children who are at high risk of progressing to severe COVID-19.
Azar said Americans would not be billed for the drug itself and that HHS was working with payers to cover the cost of administering the treatment.
Regeneron’s product approval comes shortly after the FDA cleared Eli Lilly’s further COVID-19 antibody treatment.
Azar said Monday that HHS had already distributed more than 85,000 courses of Eli Lilly’s antibody therapy to patients across the country.
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