FDA grants emergency clearance for Lilly antibody treatment

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The drug has been tested on patients inside and outside hospitals with mixed success. The National Institutes of Health ended a trial of Lilly’s antibody treatment in hospital patients with coronavirus last month because the drug did not show any benefit. Two ongoing trials are testing an antibody cocktail made by another company, Regeneron, in hospital patients, and both companies are testing their drugs in less seriously ill patients.

“The authorization of this new Eli Lilly antibody treatment is an important step in the treatment of patients and allows us to move closer to the deployment of safe and effective vaccines, all these efforts being made possible by #OperationWarpSpeedHealth and Human Services Secretary Alex Azar tweeted, referring to the government’s drug and vaccine accelerator.

It is not known why the agency acted to authorize the use of Lilly’s antibody prior to the Regeneron antibody cocktail. Last month, companies applied for emergency use authorization within days of each other.

“We are continuing productive discussions with the FDA around our submission to the EUA, but do not expect action tonight,” said a spokesperson for Regeneron.

The FDA’s action on the drug Lilly came the same day Pfizer revealed that its coronavirus vaccine was over 90% effective in early data from its Phase III trial in the United States, raising hopes that a vaccine will be available soon. But public health experts inside and outside government have noted that early vaccines are likely to be scarce, creating a gap that antibody treatments could help fill.

President Donald Trump, who received the Regeneron antibody cocktail during his fight against Covid-19 in early October and called the drug a “cure”, has pressured the FDA to quickly authorize such treatments. Clearance may make it more difficult for Regeneron and Lilly to complete their current studies, and for trials of other antibody treatments to attract participants.

Possible shortages: A major drawback of antibody treatments is that they are difficult to manufacture quickly on a large scale. Some experts, like Regeneron CEO Len Schleifer and former FDA commissioner Scott Gottlieb, have warned that there won’t be enough doses of antibody treatment for everyone who needs them.

The administration’s Operation Warp Speed ​​expects more than a million doses of infusions to be ready by the end of 2020. The Trump administration has signed a $ 450 million deal with Regeneron to deliver up to 300,000 doses of its antibody cocktail and a $ 375 million deal. with Lilly for 300,000 doses of her medicine.

The government has said it will provide these doses to Americans free of charge.

“We’ll have enough to get us into the New Year before the vaccines,” Paul Mango, HHS deputy chief of staff for policy, said in a briefing in early October.

Regeneron is working with Roche to increase manufacturing capacity and by the end of the year it could have up to 2 million doses to treat Covid-19, or between 4 million and 8 million doses to help prevent people get sick. Lilly also said he will have more than a million doses of treatment by the end of the year.

And after: Mango said last month that Warp Speed ​​would work with states to assign and distribute any antibody treatment that has received FDA clearance. The government has not disclosed what criteria it will use to determine supplies for each state. But Lilly said in a press release on Monday that she would immediately start shipping her antibody to AmerisourceBergen, the distribution company that will ship the drug on behalf of the government.



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