“This is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge,” said FDA Drug Center Director Dr. Patricia Cavazzoni. .”
Lilly says the contract for the new drug “Bebtelovimab,” pronounced “beb-teh-LO-vi-mab,” is worth at least $720 million.
The permissible dose of bebtelovimab is 175 mg given intravenously over at least 30 seconds. Significantly smaller doses and faster administration than previously approved antibody treatments for COVID-19.
“Given the emergence of variants such as omicrons, treatment options remain limited,” said Daniel Skovronsky, MD, PhD, Lilly’s Chief Medical and Scientific Officer in an approval announcement. “Lilly is pleased to offer another treatment option to help address the current needs of patients and healthcare providers who are continuing to battle this pandemic.”
The FDA’s announcement comes after two leading monoclonal antibody therapies in the United States became ineffective for Omicron. The data indicate that Lilly is also active against the emerging BA.2 mutant of Omicron.
Laboratory monoclonal antibodies represent the human body’s immune system by working to prevent viruses from entering. Given intravenously or by injection, the drug should be administered early in the course of the infection.
But late last month, the FDA, along with Lily, revoked Regeneron’s emergency use approval for the drug. Both drugs are the backbone of antibody therapy, and when they don’t work against Omicran, doctors will be under enormous pressure to come up with preventive methods.
The Department of Health & Human Services (HHS) said: “If the BA.2 subvariable grows at rates in the United States, this potential treatment will help ensure that we can continue to deliver treatment with a monoclonal antibody that works against that strain of the virus,” said in a statement announcing the agreement.
It is said that HHS will provide free treatment. Lilly has stockpiled the drug, CEO David Ricks said last month in an interview for Fierce JPM Week.
Meanwhile, Lilly is also hoping to get full approval for baricitinib, also known as Olumiant, the rheumatoid arthritis drug Incyte partnered with the company that has, according to Ricks, become the standard of care. for end-stage patients on ventilators. 46% reduced risk of death.
Earlier this month, Lilly announced COVID-19 antibody sales of $2.24 billion for 2021, with $1.06 billion in the fourth quarter.
Alternative therapies, including antivirals from Pfizer and Merck, are in short supply. GlaxoSmithKline’s antibody against Omigran was also low.
Scientists say a COVID-19 treatment like a monoclonal antibody is no substitute for vaccination.
Under the US contract with Lilly, the government will receive about 300,000 courses of the new antibody drug in February and another 300,000 in March.
Bebtelovimab was originally discovered by AbCellera Biologics (ABCL.O) and later licensed and developed by Eli Lilly.
Source: Medindia
