Eli Lilly seeks emergency FDA authorization for COVID-19 antibody drug
Eli Lilly & Co. asked U.S. drug regulators to authorize emergency use of its experimental COVID-19 antibody therapy after data showed the treatment reduced hospitalizations.
The Indianapolis-based pharmaceutical giant has approached the U. S. Food and Drug Administration for authorization of the treatment it’s developing with Canadian biotech AbCellera Biologics Inc., according to a statement Wednesday. It would allow high-risk patients recently diagnosed with mild-to-moderate COVID-19 to receive the therapy.
Antibodies from Lilly and Regeneron Pharmaceuticals Inc. could provide a powerful addition to the handful of treatments doctors are now using to treat COVID-19, which has spread around to almost 36 million people. Antibodies are considered one of the most promising potential therapies for COVID-19, and came into the spotlight last week after President Donald Trump received Regeneron’s experimental drug.
The recent surge in coronavirus cases across Europe and the U.S. underscores the need for treatments, including those of rivals, Lilly Chief Executive Officer David Ricks said Wednesday.
“We’re rooting for Regeneron’s success, as I am sure they are for ours,” he said on call with analysts and the press. “The main constraint is manufacturing capacity.”
Lilly is in near constant communication with Operation Warp Speed, the Trump administration-led program to accelerate the development and distribution of COVID-19 therapeutics and vaccines, Ricks said. With the demand high for limited supplies of the drug, it’s “best to partner with the government,” he said.
Bridge to Vaccine
The antibodies are viewed as a bridge to a vaccine, potentially helping people with early symptoms from developing severe cases that land them in the hospital. They also are being studied as short-term treatments that could rapidly be given to people such as nursing home residents or staff who may have been exposed during a local outbreak to prevent them from getting sick.
Lilly’s shares rose as much as 4% in New York. Regeneron’s gained as much as 1.8%.
The initial emergency authorization request is for a single antibody treatment, based on promising results announced last month.
Lilly is also studying a cocktail of two antibodies, and expects to approach regulators for authorization in November and seek full approval in the second quarter of 2021. Early results from a trial showed the combination reduced virus levels in patients
with mild to moderate COVID-19 and cut the rate of hospitalizations and emergency room visits.
The data “provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes,” Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in the statement.
Lilly approached regulators on the single antibody first because it already has significant amounts, Ricks said in an interview with Bloomberg TV. The cocktail, though “perhaps slightly better in some ways,” is in shorter supply, he said.
Lilly, which has an antibody manufacturing partnership with Amgen Inc., will pursue additional collaborations in the weeks to come, Ricks said. It will also seek distribution partnerships with the U.S. and other governments hoped to allow the treatments to be offered at minimal outof-pocket cost to patients, Ricks said. He didn’t provide a price that the company would charge governments for the drug, saying it would be tiered according to ability to pay.
In countries that struggle to afford the therapy, the company would take a “philanthropic approach,” he said.
Antibody Frontrunners Monoclonal antibodies are artificial versions of proteins the immune system naturally makes to fight off infection. They block the coronavirus spike protein, the same key target of vaccines.
Regeneron and Lilly are frontrunners in a burgeoning race to bring the treatments for Covid-19 to market. AstraZeneca Plc and GlaxoSmithKline Plc with its partner Vir Biotechnology Inc. also have antibody products in development.
Lilly and the closely-held AbCellera’s monotherapy antibody treatment, known as LY-Cov555, reduced the rate at which symptomatic patients were hospitalized or sent to emergency rooms compared to a placebo, according to interim study results released by the company in September. At the middle of the three doses studied, it also reduced patients’ viral load.
Lilly said it would have 100,000 doses of the singleantibody product available in October, using the lowest of three doses that have been studied, and as many as 1 million doses available by the end of the year. The different doses have not produced meaningfully different outcomes, Ricks said, and in selecting the lowest dose, Lilly can manufacture greater quantities.