Eli Lilly’s antibody neutralizing antibody bamlanivimab (LY-CoV555) is the latest bright spot in the battle against COVID-19. Despite the greenlight from the U.S. Food and Drug Administration (FDA) as an emergency treatment, there are some questions about how effective the treatment will actually prove to be due to labeling limitations.
Earlier this week, the FDA granted Emergency Use Authorization to bamlanivimab for the treatment of adults over age 65 recently diagnosed with mild-to-moderate COVID-19 and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. However, the intravenous antibody treatment is not recommended for more severely-infected patients who have been hospitalized and are on supplemental oxygen. In its announcement, Eli Lilly notes that no benefit has been seen in patients who require hospitalization. And when it comes to those who require supplemental oxygen, Eli Lilly said the use of bamlanivimab may actually worsen the condition of patients. Also, there is no language in the label about a reduction in mortality, only in hospitalization up to 28 days after treatment.
Analysts at SVB Leerink noted these limitations in a recent note to investors and suggested that some physicians may balk at administering the medication due to concerns over how to define who may be at risk of hospitalization from COVID-19.
“On the other side of the indication, to be eligible you can’t be too sick, or in need of supplemental oxygen or hospital care, because then you are too advanced, and may not benefit or may suffer harm from the medicine. We expect this limited indication to be highly confusing,” the analysts wrote, according to FiercePharma.
These concerns could spill over to Regeneron, which is developing its own monoclonal antibody treatment for COVID-19. New York-based Regeneron is also seeking EUA for its antibody cocktail, REGN-COV2. The company is seeking EUA for patients with mild-to-moderate COVID-19 who are at risk for poor outcomes. The Regeneron antibody treatment received some positive press after it was given to President Donald Trump following his diagnosis with COVID-19 last month.
Not only are some analysts raising concerns about the antibody treatment and its potential to impact the bottom line for Eli Lilly, the Infectious Disease Society of America is also reviewing clinical data associated with bamlanivimab. The association said it will issue a recommendation to its member physicians soon, Reuters reported this morning.
“It is important for clinicians and members of the public to be aware that the available data are limited, and that more information is needed to determine the effect of this therapy on clinically meaningful outcomes,” the IDSA said in a statement. “For new therapeutics to be used widely and routinely outside of clinical trials, we urge that there be sufficient safety and efficacy data to be confident regarding their use.”
Bamlanivimab is derived from the blood of a recovered patient and was first discovered by AbCellera from the blood of one of the first recovered COVID-19 patients in the United States. Bamlanivimab is a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, which should neutralize the virus, and potentially prevent and treat COVID-19.
The EUA for bamlanivimab is based on data from the Phase II BLAZE-1 study of patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. In the study, patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization.
Before the EUA was granted for the antibody treatment, Eli Lilly began manufacturing of the medication to meet demand. Lilly anticipates having about 1 million doses available by the end of 2020. Of those, about 300,000 doses are allocated to the United States through an agreement with the federal government. Next year, Lilly said it anticipates increased manufacturing for the antibody treatment as additional manufacturing resources come online throughout the year.