Eli Lilly’s coronavirus antibody drug, which former New Jersey governor Chris Christie took, was authorized for emergency use by the FDA on Monday.
The experimental drug was authorized to treat mild to moderate COVID-19 in adults and children who are at high risk of becoming sick enough to require hospitalization, but not patients who are already hospitalized or receiving oxygen. It has not received full approval from the FDA, which would require more rigorous evidence of safety and efficacy.
The treatment, known as bamlanivimab, is a lab-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 enables it to attach to and enter human cells.
Christie, a close ally of President Donald Trump’s, became one of a handful of patients to gain access to the treatment when he was infected with the coronavirus in early October. At around the same time, Trump was receiving a different experimental antibody treatment made by the company Regeneron, later touting it as a “miracle.” Both companies filed for emergency authorization shortly afterward.
The announcement was “exciting” but came with “multiple cautions,” Megan Ranney, an emergency physician and professor at Brown University, told BuzzFeed News. “Although I have high hopes for this type of medication, this data does not yet support that it is a ‘magic bullet,’” she said.
The FDA’s authorization was based on partial data from a randomized, double-blind, and placebo-controlled clinical trial involving 465 adults with mild to moderate symptoms of COVID-19. The patients receiving the therapy didn’t see a significant decrease in the amount of virus in their bodies compared to those receiving the placebo, which was the main outcome scientists were looking for.
By another measure, the drug did appear promising: Compared to the placebo group, patients on the drug had lower rates of hospitalizations and emergency room visits within 28 days of treatment. But because this was a secondary metric of success, Ranney noted that these outcomes “may or may not ultimately be clinically significant.”
As part of Operation Warp Speed, the US government signed a $375 million deal with Eli Lilly in October to supply 300,000 vials of bamlanivimab, contingent on it receiving emergency authorization, and a possible additional 650,000 vials. On Monday, Eli Lilly said it would immediately begin shipping the drug to AmerisourceBergen, a national distributor.
“We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19,” Daniel Skovronsky, Eli Lilly’s chief scientific officer, said in a statement.
Bamlanivimab’s possible side effects 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 paused by the National Institutes of Health, a sponsor of the study, due to safety concerns. It was not disclosed whether the potential safety issues were in the group receiving the treatments or the placebo.
The FDA has also issued an emergency use authorization for the use of convalescent plasma, which contains antibodies from people who have recovered from COVID-19. Scientists criticized the authorization because the agency had insufficient evidence that the treatment worked.
Allowing patients to access medications before clinical trials are finished runs the risk of discouraging patients from enrolling in those trials, where they may be given the placebo, Ranney said. The FDA’s emergency authorization of the antibody therapy “will potentially put the medication out of reach of those who need new medications most,” she wrote.
There is still no cure for COVID-19. Remdesivir, made by Gilead Sciences, is the only coronavirus treatment to win full approval so far, a move that was also criticized by scientists.
Also Monday, the drugmaker Pfizer announced the first set 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 were expecting.