The Food and Drug Administration (FDA) has told eight states to stop using COVID-19 antibody treatment because it is not effective against the new Omicron variant.
US drug regulators have warned doctors in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island and Vermont that the monoclonal antibody sotrovimab can no longer be used. used.
The FDA said this treatment, which received the green light in May 2021, is not effective in the growing BA.2 subvariant. This new variant currently accounts for 73% of COVID cases in New England, according to the CDC.
The FDA began limiting processing for this specific monoclonal antibody in February 2021.
“We will continue to monitor BA.2 in all regions of the United States and may further revise the authorization to ensure that patients with COVID-19 have effective treatments. Healthcare providers should also monitor the frequency of BA.2 in their area when choosing appropriate treatment options for patients,” the agency said.
How will this affect Massachusetts patients?
In this week’s COVID Q&A, three Boston doctors discussed the change. Dr. Sabrina Assoumou of Boston Medical Center, there are other treatment options for high-risk patients, including Pfizer’s pill, paxlovid, Gilead Sciences’ antiviral known as remdesivir, and bebtelovimab from Eli Lilly and Company, a monoclonal antibody treatment, and molnupiravir, Merck’s oral drug. processing.
She said one of the main uses of sotrovimab was for patients who tested positive for the virus, who were not yet hospitalized but were at high risk for serious complications from COVID-19.
“It’s not good that we are losing a monoclonal antibody (option) but what I also want to point out is that fortunately we have other tools in our toolbox,” she said.
Brigham and Women’s Hospital infectious disease chief Dr Daniel Kuritzkes said doctors are already calling the treatment options the most effective, a concept that dates back 100 years.
“There are all kinds of antibiotics that we don’t use because we know the bacteria are resistant,” Kuritzkes said.
“The challenge here is that we don’t have readily available tests to tell us which variant an individual patient is infected with so that within the time frame needed, i.e. a day or two, you can know which strain the patient has and whether sotrovimab would or would not be helpful or if another agent would be helpful,” he added.
He also noted that at present there are still very few treatment options with full FDA approval, and emergency use authorization comes with a certain set of restrictions and a lack of flexibility that full approval allows.
“We do not currently have fully approved antibodies. Only remdesivir is fully approved and only for hospitalized people, not for outpatients,” he said.
Dr. Shira Doron of Tufts Medical Center said the FDA’s announcement didn’t seem particularly restrictive, as doctors were already giving up on using the treatment because they didn’t find it as effective. However, she stressed that the FDA made its decision based primarily on laboratory data, not clinical data, and reassured patients who may have received sotrovimab that it was not possible. – not be totally ineffective.
All three stressed that the public should get tested as soon as they experience symptoms that could be COVID-19, and that if they test positive, they should contact their health care provider immediately.
For more information on treatment options and to find out if you are at high risk, click here.
What happens next?
Sotrovimab makers GlaxoSmithKline and Vir Biotechnology pushed back against the FDA’s claim. They said a higher dose of their treatment works for BA.2. The drugmakers have sent the FDA a set of data that backs up their claim.
Currently, the FDA indicates that the only treatment that works for BA.2 Rise. variant are Pfizer’s pill, paxlovid, Gilead Sciences’ antiviral known as remdesivir, and Eli Lilly and Company’s bebtelovimab, a monoclonal antibody treatment.