One day after the United States announced a supply deal for Eli Lilly’s new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA granted it emergency use authorization.
Bebtelovimab can be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients, age 12 and older, who are at high risk for progression to severe COVID-19.
The treatment has been shown to be active against the omicron variant. Three weeks ago, Lilly’s antibody cocktail of bamlanivimab and etesevimab was banned by the FDA because it was shown to be ineffective against omicron. Regeneron’s antibody, REGEN-COV, also was grounded that day for the same reason.
The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. The dosage is considerably smaller and quicker to administer than previous antibody treatments approved for COVID-19.
“With the emergence of variants such as omicron, treatment options remain limited,” Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, said in an announcement of the approval. “Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and healthcare providers, who continue to battle this pandemic.”
The endorsement is based on the analyses of the phase 2 BLAZE-4 trial of nonhospitalized patients who were treated with bebtelovimab alone or together with bamlanivimab and etesevimab. Pseudovirus and authentic virus testing showed that bebtelovimab retained full neutralizing activity against omicron. In addition, the drug demonstrated neutralization against all other known variants of interest including omicron’s emerging subvariant BA.2.
The U.S. has agreed to a $720 million deal for bebtelovimab. Lilly will supply 600,000 courses of the treatment—300, 000 this month and 300,000 by the end of next month. The U.S. will have the option to buy 500,000 more antibody courses to be delivered by July 31.
“Should the BA.2 subvariant grow in proportion in the U.S., this potential treatment will help ensure that we can continue to offer a monoclonal antibody treatment that works against that strain of the virus,” the Department of Health & Human Services said in a statement announcing the deal.
The HHS will provide the treatment for free, it said. Lilly has been stockpiling the treatment, CEO David Ricks said last month in an interview for Fierce JPM Week.
Meanwhile, Lilly also is hoping for a full approval for baricitinib, also known as Olumiant, the company’s Incyte-partnered rheumatoid arthritis drug, which according to Ricks, has become the standard-of-care for late-stage patients on ventilators, as it reduces the risk of death by 46%.
Earlier this month, Lilly announced COVID-19 antibody sales of $2.24 billion for 2021, with $1.06 billion coming in the fourth quarter.
