Eli Lilly ready to ship 100,000 doses of Covid drug; waiting for FDA nod

The US government agreed to pay Eli Lilly & Co $375 million for 300,000 vials of its experimental Covid-19 antibody as it undergoes regulatory review for emergency-use authorisation.
 

The funding from Operation Warp Speed, the White House-led effort to quickly secure Covid-19 vaccines and therapeutics, hinges on Lilly’s antibody therapy receiving a green light from the US Food and Drug Administration (FDA). The initial agreement is for delivery over the first two months following an emergency authorisation. The US has the option to purchase an additional 650,000 vials through next June for as much as $812.5 million, according to a Wednesday statement by the US Department of Health and Human Services.

 

Lilly approached US regulators for an emergency-use authorisation in early October after promising data showed the therapy helped reduce hospitalisations in patients with less-severe cases. The preliminary agreement prices the treatment at $1,250 per 700-milligram dose, or about half the cost of remdesivir, the Gilead Sciences antiviral that’s already approved to treat hospitalised patients. Wall Street had expected a higher price.
 

Shares of the Indianapolis-based drugmaker fell less than a percent at 9:33 am to $130.86 in New York trading.
 

If the authorisation is granted, the US has made a commitment that patients will have no out-of-pocket costs tied to the medicine, Lilly said in a statement, though health-care facilities could charge for the product’s intravenous administration. The first vials would go to patients with mild to moderate symptoms. Lilly said it is working with Operation Warp Speed to aid federal and state efforts to create locations where patients can get the treatment.