Eli Lilly's COVID-19 Antibody Drug is Authorized by US FDA

The US Food and Drug Administration has cleared the Eli Lilly drug for adults and adolescent patients with mild-to-moderate cases of COVID-19.

The Food and Drug Administration (FDA) has approved Eli Lilly for adult and adolescent patients with mild-to-moderate cases of COVID-19. Lilly announced treatment work late last year after testing revealed that its previous antibody therapy was ineffective against the dominant omicron variant of COVID-19.

Biden administration has purchased 600,000 doses prior to approval and will begin shipping initial supplies to state health officials for distribution.

‘The Food and Drug Administration (FDA) has approved Eli Lilly for adult and adolescent patients with mild-to-moderate cases of COVID-19.’

FDA's Drug Center Director Dr. Patricia Cavazzoni said, "It is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge."

Lilly said that the contract for its new drug "Bebtelovimab," pronounced “beb-teh-LO-vi-mab,” is worth a minimum value of $720 million.

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.

Daniel Skovronsky, MD, PhD, Lilly's Chief Scientific and Medical Officer said, in an announcement of the approval, “With the emergence of variants such as omicron, treatment options remain limited.” “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 FDA announcement comes after two leading monoclonal antibody therapies in the United States became ineffective against Omicron. Data indicate that the Lilly drug also acts against the emerging BA.2 mutation of Omicron.

Laboratory monoclonal antibodies stand for the human body's immune system by acting to block the invading virus. Given by IV or injection, medications should be used 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 were the backbone of antibody therapy, and when they did not work against Omicran doctors were under intense pressure to bring in fallbacks.

“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 (HHS) said in a statement announcing the deal.

It is said that the HHS will provide free treatment. 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.

Alternative therapies, including antiviral pills from Pfizer and Merck, are in short supply. GlaxoSmithKline's antibody against Omigran is also low.

Scientists say that COVID-19 treatments like monoclonal antibodies are not a substitute for vaccination.

Under the U.S. contract with Lilly, the government will receive about 300,000 treatment 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