Eli Lilly and Company has been handed another sweetheart contract that brings it $720,000 for 600,000 doses of investigational drug bebtelovimab.
That’s $1,200 a dose at a time when our biggest states, including California – controlled by Democrats – are removing mask mandates and other restrictions as the COVID-19 crisis rapidly fades away.
That is not stopping the White House from buying more drugs under the pretense they are necessary, and offering them to the public at so-called no cost to the individual patient – just put it on the bill of the poor taxpayer.
The U.S. government on Friday accepted the use of bebtelovimab after the FDA granted an Emergency Use Authorization (EUA), clearing the way for the drug’s sale.
In approving the drug, the FDA warned:
Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Biden has also agreed to buy an additional $600 million worth of bebtelovimab to be delivered before July 31.
The 2022 Ely Lilly estimated financial impact of this agreement is at least $720 million of revenue and approximately $0.20 of Earnings per Share (EPS), not even counting the $600 million second-wave Biden purchase.
All told, we will spend $1.32 billion for an emergency-use drug (if even approved by the rubber-stamp FDA) at a time when it appears there is no more emergency.
The treatment was discovered by AbCellera and the scientists at the taxpayer-funded National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. One of the directors of AbCellera is Peter Thiel, a Donald Trump supporter and founder of PayPal.
Ely Lilly said the FDAwill monitor conditions to determine whether use in a geographic region is medically appropriate, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
This purchase is with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).
ELY Lilly is not a big spender through affiliates on aiding political campaigns, and reports show money only going to this very strange cast of characters: Joe Biden, Mitch McConnell, Pete Buttigieg, and Christina Halle, an Indiana Congressional candidate.
The FDA’s decision for emergency use included this information:
Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death.
The FDA is carefully monitoring circulating viral variants and their sensitivity to authorized monoclonal antibodies, including bebtelovimab. Laboratory testing showed that bebtelovimab retains activity against both the omicron variant and the BA.2 omicron subvariant.
The placebo-controlled portion of the trial enrolled 380 low-risk patients (i.e., patients without risk factors for progression to severe COVID-19 illness). Patients in this part of the trial were randomized to receive a single infusion of bebtelovimab alone, bebtelovimab with other monoclonal antibodies or a placebo. Treatment with bebtelovimab resulted in a reduction in time to sustained symptom resolution compared to placebo. Reduction in viral load relative to placebo was also seen on Day 5 after treatment.
In another part of the trial involving mostly high-risk individuals (i.e. patients with risk factors for progression to severe COVID-19 illness), 150 patients were randomized to receive a single infusion of bebtelovimab alone or a single infusion of bebtelovimab with other monoclonal antibodies. An additional 176 high-risk patients received bebtelovimab with other monoclonal antibodies in an open-label treatment arm.
The rates of COVID-19 related hospitalization and death through Day 29 seen in those who received bebtelovimab alone or with other monoclonal antibodies were generally lower than the placebo rate reported in prior trials of other monoclonal antibodies in high risk patients. Conclusions are limited as these data are from different trials that were conducted when different viral variants were circulating and baseline risk factors varied.
Clinical data were similar for bebtelovimab alone as compared to the combination of bebtelovimab with other monoclonal antibodies.
Possible side effects of bebtelovimab include itching, rash, infusion-related reactions, nausea and vomiting.
Serious and unexpected adverse events including hypersensitivity, anaphylaxis and infusion-related reactions have been observed with other SARS-CoV2 monoclonal antibodies and could occur with bebtelovimab. In addition, clinical worsening following administration of other SARS-CoV-2 monoclonal antibody treatment has been reported and therefore is possible with bebtelovimab. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.