Antiviral remdesivir donated by Gilead Sciences is being shipped to areas in the US hardest hit by COVID-19.
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The Department of Health and Human Services has commenced shipment of the antiviral remdesivir to state health departments for treatment of hospitalized patients with COVID-19.
In a press release dated May 9, 2020, the Office of the Assistant Secretary for Preparedness and Response (ASPR) announced the allocation plan that began on May 7 with delivery of cases of the drug to: Connecticut (30 cases), Illinois (140 cases), Iowa (10 cases), Maryland (30 cases), Michigan (40 cases) and New Jersey (110 cases). Each case contains 40 vials of the donated drug.
Candidates for the dontaed remdesivir are patients requiring mechanical ventilation or with Sa02 ≤94% on room air. Remdesivir received Emergency Use Authorization (EUA) from the FDA on May 1, allowing healthcare providers to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
Under terms of the EUA, remdesivir manufacturer Gilead Sciences is committed to suppyling approximately 607,000 vials of remdesivir over the next 6 weeks to treat an estimated 78,000 patients hospitalized with COVID-19. The US donation is a portion of 1.5 million vials of the drug the company is donating globally.
Distribution decisions are local
According to the HHS statement, decisions on distribution of remdesivir to hospitals will be made by state health departments, given their insight into specific community-level needs in the COVID-19 response. Local judgements are required to ensure appropriate distribution of the limited supply of the treatment.
An initial allocation was sent to 7 states: Indiana (38 cases), Massachusetts (117 cases), New Jersey (94 cases), New York (565 cases), Rhode Island (30 cases), Tennessee (7 cases), and Virginia (33 cases).
ASPR expects cases to be delivered to all 50 states as well as various territories.
NIH and Gilead Sciences collaborated on a randomized controlled clinical trial of the investigational drug in hospitalized patients. Preliminary results suggested that remdesivir was associated with faster recovery, although data were not sufficient to determine if the drug was associated with lower mortality.
Accompanying the EUA, the FDA provided a fact sheet for healthcare providers administering the drug to patients and a separate fact sheet for patients and caregivers.
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