What is bamlanivimab? FDA authorizes Eli Lilly’s coronavirus antibody treatment for emergency use
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Eli Lilly’s antibody therapy bamlanivimab for the treatment of mild-to-moderate Covid-19 in adult and pediatric patients. The agency specifies that Bamlanivimab is authorized for patients who have tested positive for coronavirus, who are 12 years of age and older, who weigh at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe Covid-19 and/or hospitalization. This includes those who are 65 years of age or older, or those who have certain chronic medical conditions.
Bamlanivimab is a monoclonal antibody. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. President Donald Trump received a similar experimental treatment -- an antibody cocktail made by Regeneron on an emergency basis after he was diagnosed with coronavirus.
“While the safety and effectiveness of this investigational therapy continue to be evaluated, bamlanivimab was shown in clinical trials to reduce Covid-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” says the FDA.
Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the US government’s allocation program. “This emergency authorization allows us to make bamlanivimab available as a Covid-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” notes David A Ricks, Lilly's chairman, and CEO.
According to the company, the US government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication. While Lilly did not specify how many doses are currently ready to go, it said that it could have as many as 1 million doses available by the end of the year. “Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020, for use around the world through early next year. Beginning in Q1 (first quarter) 2021, the supply of Lilly’s antibody therapy is expected to increase substantially, as additional manufacturing resources come online throughout the year,” it adds.
Therapy not for patients already hospitalized
However, the antibody treatment is not authorized for patients who are hospitalized due to Covid-19 or require oxygen therapy due to the infection as a benefit of bamlanivimab treatment has not been shown in hospitalized coronavirus patients. The FDA also warns that monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with coronavirus requiring high flow oxygen or mechanical ventilation.
The issuance of EUA is different from FDA approval. In determining whether to issue an emergency use authorization, the FDA evaluates the available evidence and balances any known or potential risks with any known or potential benefits of the product for use during an emergency.
“Based on the FDA’s review of the totality of the scientific evidence available, the agency determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate Covid-19. And, when used to treat Covid-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug. There are no adequate, approved, and available alternative treatments to bamlanivimab for the authorized population,” the agency explains.
What is the evidence supporting EUA?
The data supporting this EUA for bamlanivimab are based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial in 465 non-hospitalized adults with mild to moderate coronavirus symptoms. Of these patients, 101 received a 700-milligram dose of bamlanivimab, 107 received a 2,800-milligram dose, 101 received a 7,000-milligram dose and 156 received a placebo within three days of obtaining the clinical sample for the first positive SARS-CoV-2 viral test. “The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo,” say experts.
Most patients, including those receiving placebo, cleared the virus by day 11. “However, the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of Covid-19-related hospitalizations or emergency room visits within 28 days after treatment,” analysis reveals. For patients at high risk for disease progression, hospitalizations, and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients. The effects on viral load and reduction in hospitalizations and ER visits, and on safety, were similar in patients receiving any of the three bamlanivimab doses.
“The BLAZE-1 (trial) data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce Covid-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” explains said Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories.
The possible side effects of bamlanivimab include nausea, diarrhea, dizziness, headache, itching and vomiting. “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,” says FDA Commissioner Stephen M Hahn.