A new monoclonal antibody drug has become available in the U.S., as the Food and Drug Administration (FDA) authorized Ely Lilly’s bebtelovimab for use in non-hospitalized Covid patients who are at a high risk of severe complications from the virus.
The move comes only weeks after the agency pulled authorization from another monoclonal antibody treatment produced by Eli Lilly – along with a drug produced by Regeneron – since they were deemed to be ineffective against the Omicron variant.
This drug showed effectiveness against the strain that now makes up nearly 100 percent of active cases in the U.S., though, and will soon begin to be administered to infected patients.
Monoclonal antibody drugs were considered to be the top treatment for the virus after a person was already infected, though administering the drugs is very resource intensive so officials have instead showed preference towards antiviral pills like molnupiravir and Paxlovid in recent weeks.
Eli Lilly’s new monoclonal antibody drug has been approved by the FDA, only weeks after their previous Covid-fighting drug had its authorization pulled for not being effective against the Omicron variant (file photo)
Monoclonal antibody drugs are highly effective against Covid, but are also more expensive and resource intensive to administer (file photo)
‘Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,’ said Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
‘This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.’
The United States has already purchased 600,000 doses of the drug for $720 million, which will be distributed for free to Americans in need. The deal was pending FDA authorization.
Before July 31, the U.S. is allowed to purchase 500,000 more doses at a pre-arraigned price.
Trials for the drug included two parts, one with a low risk and one with a high risk population group.
The low risk group included 380 people, and the drug was tested alone and alongside other similar drugs. The FDA reports the trials found a ‘sustained’ resolution of symptoms among people who received the drug.
A second trial for high risk individuals included 150 patients. There was no placebo group in this trial, with half the patients receiving bebtelovimab alone and half receiving it mixed with another drug.
The drug was effective at preventing hospitalization and death from Covid in the high risk group as well, and it is equally effective when used alone as it is when used along with another available monoclonal antibody drug.
Monoclonal antibody drugs were the most effective treatment against the virus until very recently when more effective, easier to administer, antiviral pills began to hit the market.
The antibodies are still valuable tools, though. The drugs pump a person’s body full of virus fighting antibodies that are similar to those generated by vaccination or natural immunity from previous infection.
Those antibodies then assist a person’s immune system in stopping the virus from replicating and neutralizing infected cells.
The drugs have been a favorite of some conservative politicians like former President Donald Trump and Florida Gov Ron DeSantis.
Monoclonal antibody drugs do come with some major downsides. Some experts believe a focus on them, especially in conservative circles, has given the indication that the drug can replace the vaccines – which the FDA notes is not the case.
Administering the drugs can be a challenge for hospitals as well, especially during times where they are near capacity due to case surges.
A patient receiving the drugs requires constant monitoring and also a lot of tubing and machinery. Monoclonal antibodies are also significantly more expensive than the vaccines.
The FDA pulling the drugs last month for being ineffective against Omicron was a controversial decision that DeSantis described as ‘authoritarianism’.
The agency stood by its decision, though, and has no brought Eli Lilly’s monoclonal antibodies back into the mix with this recent authorization.