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Eli Lilly’s coronavirus antibody drug, taken by former New Jersey Governor Chris Christie, was cleared for emergency use by the FDA on Monday.
The investigational drug has been licensed for the treatment of mild to moderate COVID-19 in adults and children at high risk of getting sick enough to require hospitalization, but not in patients already hospitalized or receiving oxygen. It has not received full approval from the FDA, which would require more rigorous testing of safety and efficacy.
The treatment, known as bamlanivimab, is a laboratory-made version of an antibody, one of the immune system’s natural defenders against viruses and other invaders. The synthetic antibody is designed to target the coronavirus spike protein, which allows it to attach to and enter human cells.
Christie, a close ally of President Donald Trump, became one of the few patients who had access to treatment when he was infected with the coronavirus in early October. Around the same time, Trump was receiving a different experimental antibody treatment made by the Regeneron company, later advertising it as a “miracle”. Both companies filed for emergency clearance shortly thereafter.
The announcement was “exciting” but came with “multiple cautions,” Megan Ranney, an emergency physician and professor at Brown University, told BuzzFeed News. “While I have high hopes for this type of drug, these data still don’t support it as a ‘magic bullet’,” he said.
FDA clearance was based on partial data from a randomized, double-blind, placebo-controlled clinical trial involving 465 adults with mild to moderate symptoms of COVID-19. Patients who received the therapy did not see a significant decrease in the amount of the virus in their bodies compared to those who received the placebo, which was the main result the scientists were looking for.
According to another measure, the drug looked promising: Compared to the placebo group, patients taking the drug had lower rates of hospitalizations and emergency room visits within 28 days of treatment. But because this was a secondary success metric, Ranney noted that these results “may or may not be clinically significant.”
As part of Operation Warp Speed, the US government signed a $ 375 million deal with Eli Lilly in October to provide 300,000 vials of bamlanivimab, provided he receives emergency clearance, and an additional 650,000 vials. On Monday, Eli Lilly said it will immediately begin shipping the drug to AmerisourceBergen, a national distributor.
“We are proud of the speed with which we have been able to bring this therapy specifically designed to treat COVID-19 to patients,” Daniel Skovronsky, scientific director of Eli Lilly, said in a statement.
Possible side effects of Bamlanivimab include allergic reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.
Last month, a clinical trial that was testing bamlanivimab, along with the antiviral remdesivir, in hospitalized patients was suspended by the National Institutes of Health, a sponsor of the study, due to safety concerns. It was not revealed whether the potential safety concerns were in the group receiving the treatments or the placebo.
The FDA has also issued an emergency use permit for the use of convalescent plasma, which contains antibodies from people who have recovered from COVID-19. Scientists criticized the authorization because the agency did not have sufficient evidence that the treatment worked.
Allowing patients to access drugs before clinical trials are completed runs the risk of discouraging patients from enrolling in those trials, where they can receive placebo, Ranney said. The FDA’s emergency clearance for antibody therapy “will potentially put the drug out of reach for those who need new drugs most,” he wrote.
There is still no cure for COVID-19. Remdesivir, made by Gilead Sciences, is the only coronavirus treatment to gain full approval so far, a move that has also been criticized by scientists.
Also on Monday, pharmaceutical manufacturer Pfizer announced the first batch of results from a late-stage coronavirus vaccine trial. According to the company, early data showed that its vaccine was at least 90% effective, a much higher degree of protection than outside researchers expected.
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