Setback for B.C.’s AbCellera as FDA pulls U.S. authorization for its COVID-19 antibody

المملكة العربية السعودية أخبار أخبار

Setback for B.C.’s AbCellera as FDA pulls U.S. authorization for its COVID-19 antibody
المملكة العربية السعودية أحدث الأخبار,المملكة العربية السعودية عناوين
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Bebtelovimab, developed in partnership with Eli Lilly, got emergency okay for sale in February

after determining the drug, called bebtelovimab, is not expected to neutralize the two latest subvariants of the virus’s dominant Omicron strain.monoclonal antibody treatment, leaving antiviral drugs from Pfizer, Merck and Gilead Sciences as treatments for the disease, as well as convalescent plasma for some patients. AstraZeneca’s antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its distributors have paused commercial distribution of the antibody until further notice from the FDA, while the U.S. government has paused fulfillment of any pending requests under its scheme to help Americans access the drug. Bebtelovimab received emergency authorization from the FDA in February.

The FDA first disclosed in early November the Eli Lilly/AbCellera molecule was unlikely to work against the two Omicron subvariants, so Wednesday’s announcement was expected, Bloom Burton analyst Antonia Borovina said in an e-mail. That throws into question how much AbCellera can continue to earn from its COVID-19 drugs. Ms. Borovina slashed her forecast for fourth-quarter revenue related to the COVID-19 antibodies to US$47.3-million from US$143-million – and to zero in the next two years – after the earlier FDA warning. She said she could revisit her forecast if the pair’s next drug wins approval. AbCellera has earned US$959-million in highly profitable royalties from its COVID-19 antibodies to date.

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المملكة العربية السعودية أحدث الأخبار, المملكة العربية السعودية عناوين

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