The United States has already secured hundreds of thousands of doses of experimental antibody treatments for Covid-19 in anticipation of regulators authorizing their emergency use, federal health officials said Friday.
The government hopes to have 1 million doses of so-called monoclonal antibody treatments on hand before the end of the year.
Treatments have come into the limelight after President Donald Trump received one of those experimental therapies last week for his Covid-19 case.
Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. applied this week to the US Food and Drug Administration for emergency use authorizations for their antibody therapies, but have not yet received authorization. Since then, Trump has repeatedly promised to speed up their approval, expand access, and provide them to Americans for free.
“We have already entered into a series of contracts for the procurement of these monoclonal antibodies,” said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services. The government is purchasing doses through its National Strategic Reserve as they are manufactured, he said.
Mango spoke during a briefing on the latest developments in Operation Warp Speed, the White House-led effort to accelerate the development, manufacture and distribution of coronavirus vaccines and treatments.
Early data from Lilly’s single antibody and Regeneron’s antibody cocktail suggest that both are effective in keeping people infected with the novel coronavirus out of the hospital.
“Interest in monoclonal antibodies is quite high,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. Woodcock, who is serving as part of Operation Warp Speed, has refrained from participating in approval decisions related to coronavirus therapeutics.
Biggest challenge
Healthcare experts and industry executives have said that manufacturing represents the most important challenge in getting antibody treatments to all who may need them. The process is expensive, and demand is likely to exceed supply.
Lilly said earlier this week that it would have 100,000 doses of the unique antibody product it is developing with Canadian biotech AbCellera Biologics Inc. available in October, and up to 1 million doses available by the end of the year.
The Indianapolis-based pharmaceutical giant is also studying a two-antibody cocktail and hopes to approach regulators for authorization in November and seek full approval in the second quarter of 2021. Supplies of the cocktail, which adds a second antibody that Lilly licensed Shanghai Junshi Biosciences Co., are much more limited, with only about 50,000 doses available this year.
Regeneron said Wednesday that it has sufficient doses for about 50,000 patients and hopes to have sufficient doses available for 300,000 patients in the coming months. Warp Speed officials said the distribution plan will be similar to remdesivir, with the federal government targeting states with the greatest need.
The biggest challenge ahead, Woodcock said, will be coordinating where patients can receive antibody treatments, which must be administered intravenously by healthcare professionals, as opposed to vaccines, which can be administered from the most confines. convenient from a pharmacy.
.
