Eli Lilly and AbCellera Win EUA for COVID-19 Antibody Treatment
Eli Lilly antibody quality testing process. Photo courtesy of Eli Lilly.
Eli Lilly and Vancouver-based AbCellera won Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for adults and some pediatric COVID-19 patients.
The U.S. Food and Drug Administration (FDA) authorized the EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in adults 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. Bamlanivimab, an intravenous treatment, should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
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.
Bamlanivimab was the first monoclonal antibody therapy for COVID-19 to enter human testing in the United States and is currently undergoing multiple Phase I, II and III clinical trials. The two companies were able to get their antibody candidate into the clinic within two months of announcing their collaboration in response to the global pandemic.
David A. Ricks, chairman and chief executive officer of Eli Lilly, said the EUA allows the company to make bamlanivimab available for newly-diagnosed, high-risk patients and creates a valuable new tool for doctors.
“The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most,” Ricks said in a statement.
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.
Therapeutic antibodies can be beneficial for patients, but are unlikely to replace any vaccine that is successfully developed for COVID-19. The treatments are generally viewed as a stopgap measure.
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.
Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories, said the data from the BLAZE-1 study show early treatment with bamlanivimab may help patients clear the virus and reduce COVID-related hospitalizations.
Even before the EUA was granted for the antibody treatment, Eli Lilly had already begun 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. Eli Lilly said it will immediately begin shipping doses of bamlanivimab to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government's allocation program. In 2021, Lilly said it anticipates increased manufacturing for the antibody treatment as additional manufacturing resources come online throughout the year.
“We commend the Lilly team for their tireless efforts to combat COVID-19 and for starting antibody manufacturing at risk in advance of clinical results. Because of this, there is now an opportunity to have a near-term impact against COVID-19, manufacturing up to one million doses of bamlanivimab to patients before the end of the year,” Carl Hansen CEO of AbCellera said in a statement.