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Eli Lilly's bamlanivimab became the first by the FDA.

Bamlanivimab was authorized to treat mild to moderate COVID-19 in both adult and pediatric patients who weigh at least 88 pounds and are at high risk of progressing to severe disease, the agency said Monday. The therapy is to be administered intravenously as a single dose by healthcare providers.

However, the FDA emphasized bamlanivimab was not for patients hospitalized with severe COVID-19 or who require oxygen therapy, and in fact noted that monoclonal antibodies may "be associated with worse clinical outcomes" in hospitalized patients "who require high-flow oxygen or mechanical ventilation." Lilly recently said it with the drug in this population.

Bamlanivimab is a recombinant monoclonal antibody targeting the SARS-CoV-2 spike protein. The U.S. government has contracted to buy 300,000 doses, to begin shipping immediately to distributor AmerisourceBergen, . HHS said in a statement that it has through June 2021. The Trump administration has committed to providing the drug without cost to patients, working through the Center for Medicare and Medicaid Services and payors for reimbursement costs, HHS officials added during a media call on Tuesday.

"Weekly allocation decisions will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data from the U.S. Department of Health and Human Services' Protect data collection platform," Lilly said. "Each week, state and territorial health departments will select sites of care (that are accessible and can minimize infection transmission) to receive allocated doses and will provide AmerisourceBergen the list of sites. Sites of care will then confirm their need and AmerisourceBergen will distribute bamlanivimab overnight."

HHS officials said the company has 80,000 doses available this week slated for hospitals, outpatient clinics, and alternative care settings. Lilly indicated it expects to produce "up to one million doses" by the end of 2020 with manufacturing capacity to "increase substantially" in 2021.

Authorization was based on interim analysis of a of 465 non-hospitalized adults with COVID-19 symptoms, in which patients were randomized to 700, 2,800 or 7,000 mg of bamlanivimab or placebo within 3 days of testing positive for SARS-CoV-2. Effects on viral load, hospital visits and safety were similar in all three drug doses of the therapy, the agency said.

The FDA said it was particularly impressed with bamlanivimab's effectiveness for the secondary endpoint of COVID-19 hospitalizations or emergency room visits within 28 days after treatment (3% in intervention vs 10% in placebo). The primary endpoint was change in viral load from baseline to day 11, with most patients, including those in the placebo group, clearing the virus within that timeframe.

Side effects of bamlanivimab include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching and vomiting.

HHS noted that, under the EUA, the drug can only be administered in facilities with immediate access to medications to treat severe infusion reaction such as anaphylaxis, the ability to activate emergency responses, and space to administer the medication in a way to prevent infection transmission.

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