The Food and Drug Administration said a Covid-19 antibody treatment from
Eli Lilly
& Co. is no longer authorized for use because it isn’t likely to be effective against certain Omicron offshoots now dominant in the U.S.
The subvariants, called BQ. 1 and BQ. 1.1, now cause more than half of new Covid-19 cases in the U.S., the FDA said on Wednesday. Yet Lilly’s drug, bebtelovimab, doesn’t retain neutralizing activity against the subvariants, the company said.
“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate Covid-19 with bebtelovimab in the U.S.,” Lilly said.
Bebtelovimab was among the Covid-19 antibody drugs still authorized for use as a treatment for sick patients, after the FDA pulled clearances of others.
Roche Holding AG’s
Actemra antibody drug is also still in use as a treatment, though it wasn’t developed specifically for Covid-19.
Evusheld, an antibody drug from
AstraZeneca
PLC, is still cleared to prevent infections.
The FDA said other Covid-19 treatments are still expected to retain activity against BQ. 1 and BQ. 1.1, including
Pfizer Inc.’s
Paxlovid and
Gilead Sciences Inc.’s
Veklury.
Lilly, of Indianapolis, said it has paused distribution of bebtelovimab until further notice by the agency.
The FDA and the company advised healthcare providers to store any unused bebtelovimab, in case other coronavirus variants that are susceptible to the drug become more prevalent.
Bebtelovimab is one of several monoclonal antibodies that have been developed to treat Covid-19 since 2020. They work by mimicking immune system antibodies to neutralize the virus and have largely been used to reduce the risk of hospitalization and death in people with mild to moderate cases of Covid-19.
Some of the earlier monoclonal antibodies, including those from Lilly and
Regeneron Pharmaceuticals Inc.,
lost their effectiveness against the Omicron variant. U.S. regulators restricted use of the older antibodies in January.
The FDA authorized the use of Lilly’s bebtelovimab in February, finding that it retained neutralization of earlier Omicron subvariants.
AstraZeneca’s Evusheld is authorized for pre-exposure prevention of Covid-19 in immunocompromised people and those unable to get a Covid-19 vaccine.
Lilly said it would search for and evaluate monoclonal antibodies that might work against new variants.
Write to Peter Loftus at Peter.Loftus@wsj.com
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
The Food and Drug Administration said a Covid-19 antibody treatment from
Eli Lilly
& Co. is no longer authorized for use because it isn’t likely to be effective against certain Omicron offshoots now dominant in the U.S.
The subvariants, called BQ. 1 and BQ. 1.1, now cause more than half of new Covid-19 cases in the U.S., the FDA said on Wednesday. Yet Lilly’s drug, bebtelovimab, doesn’t retain neutralizing activity against the subvariants, the company said.
“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate Covid-19 with bebtelovimab in the U.S.,” Lilly said.
Bebtelovimab was among the Covid-19 antibody drugs still authorized for use as a treatment for sick patients, after the FDA pulled clearances of others.
Roche Holding AG’s
Actemra antibody drug is also still in use as a treatment, though it wasn’t developed specifically for Covid-19.
Evusheld, an antibody drug from
AstraZeneca
PLC, is still cleared to prevent infections.
The FDA said other Covid-19 treatments are still expected to retain activity against BQ. 1 and BQ. 1.1, including
Pfizer Inc.’s
Paxlovid and
Gilead Sciences Inc.’s
Veklury.
Lilly, of Indianapolis, said it has paused distribution of bebtelovimab until further notice by the agency.
The FDA and the company advised healthcare providers to store any unused bebtelovimab, in case other coronavirus variants that are susceptible to the drug become more prevalent.
Bebtelovimab is one of several monoclonal antibodies that have been developed to treat Covid-19 since 2020. They work by mimicking immune system antibodies to neutralize the virus and have largely been used to reduce the risk of hospitalization and death in people with mild to moderate cases of Covid-19.
Some of the earlier monoclonal antibodies, including those from Lilly and
Regeneron Pharmaceuticals Inc.,
lost their effectiveness against the Omicron variant. U.S. regulators restricted use of the older antibodies in January.
The FDA authorized the use of Lilly’s bebtelovimab in February, finding that it retained neutralization of earlier Omicron subvariants.
AstraZeneca’s Evusheld is authorized for pre-exposure prevention of Covid-19 in immunocompromised people and those unable to get a Covid-19 vaccine.
Lilly said it would search for and evaluate monoclonal antibodies that might work against new variants.
Write to Peter Loftus at Peter.Loftus@wsj.com
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8