Lilly asks FDA to not allow lone use of COVID-19 drug bamlanivimab
- The request made to the US Food and Drug Administration is not due to any new safety issues, but in response to the new variants in the country that could be resistant to bamlanivimab when used alone, the drugmaker said in a statement.
- Hospitals with bamlanivimab supply should now order etesevimab to pair with it, Lilly said.
Eli Lilly and Co said it had requested for cancellation of the US authorization granted to its COVID-19 antibody, bamlanivimab, which will now be used in combination with another to achieve greater efficacy against emerging virus variants.
The request made to the US Food and Drug Administration is not due to any new safety issues, but in response to the new variants in the country that could be resistant to bamlanivimab when used alone, the drugmaker said in a statement.
The US government stopped the distribution of the therapy last month.
Hospitals with bamlanivimab supply should now order etesevimab to pair with it, Lilly said.
Earlier this week, Lilly revised its pact with the US government to enable the supply of etesevimab to complement doses of bamlanivimab that the government had already purchased.
Etesevimab and bamlanivimab together neutralize more emerging COVID-19 variants in the US than bamlanivimab alone, including the rapidly growing B.1.427/B.1.429 California strain, Lilly said on Friday.
Lilly said it was not seeking cancellation of bamlanivimab's authorization in other countries, but its use was preferred in combination with etesevimab.
The drugmaker said it expects to make enough of the cocktail therapy along with partner Amgen to meet global supply needs.
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