EUA for COVID antibody calls for additional plant oversight

Regulatory NewsRegulatory News | 10 November 2020 |  By 

The US Food and Drug Administration (FDA) has granted an emergency use authorization for an outpatient therapy to treat mild to moderate COVID-19. The monoclonal antibody, bamlanivimab, is authorized for outpatient use in adults and pediatric patients who are at least 12 years old and weigh at least 40 kg.
The treatment is reserved for patients who have positive direct SARS-CoV-2 viral tests – not antigen tests – and who are “at high risk for progressing to severe COVID-19 and/or hospitalization,” according to the FDA’s 9 November letter of authorization issued to bamlanivimab’s sponsor, Eli Lilly and Company. In announcing the emergency use authorization (EUA), FDA noted that high risk conditions can include obesity, other chronic medical problems and being 65 years old, or older.
The newly authorized treatment is a neutralizing IgG1 monoclonal antibody that binds to the spike protein of the SARS-CoV-2 virus. It must be administered by infusion and it must be kept at refrigerated temperatures and away from light until use, though it may be held at room temperature for a total of 7 hours, including the time required to infuse the antibody. Administration must occur in a setting that can manage severe infusion reactions including anaphylaxis.
The conditions of the EUA granted to Lilly include a specific directive to retain an independent third party to review batch records and “any underlying data and associated discrepancies” of the drug substance,  with the conditions imposed on just one of Lilly’s manufacturing sites.
The site in question, Lilly’s facility in Branchburg, NJ, was the subject of a November 2019 inspection that resulted in a determination of Official Action Indicated. “The inspectors had some findings related to data handling,” observed Lilly in a 20 October press release. The firm revealed that they had engaged an external consultant “to review our detailed Branchburg manufacturing and quality records for bamlanivimab.”
The US government reached an agreement with Lilly on 28 October to procure 300,000 vials of bamlanivimab for $375,000,000, conditional on the antibody’s receiving an EUA. The government has the option of procuring an additional 650,000 vials by the end of June 2021.
In the press release announcing the agreement, Lilly noted that the government has committed to no patients incurring out-of-pocket expenses for bamlanivimab – though facilities may charge fees for administering infusions. These fees can run into the thousands of dollars for a single infusion, according to recent research.
“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD, in the agency's press release.
The EUA for bamlanivimab was based on a planned interim analysis of an ongoing randomized, double-blind, placebo-controlled trial of the antibody as monotherapy for outpatients with mild to moderate COVID-19. FDA found that for the specified patient population, “it is reasonable to believe that bamlanivimab may be effective” to treat mild to moderate COVID-19.
The scope of authorization for the antibody specifically excludes hospitalized patients, as well as those who require new oxygen therapy for COVID-19 or whose chronic oxygen requirements escalate while ill with COVID-19.
EUA Letter


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Tags: coronavirus, FDA, US

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