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FDA Announces Evusheld is Not Currently Authorized for Emergency Use in the U.S.

In science and medicine, information is constantly changing and may become out-of-date as new data emerge. All articles and interviews are informational only, should never be considered medical advice, and should never be acted on without review with your health care team.

As of 1/26/23, Evusheld (tixagevimab co-packaged with cilgavimab) is no longer available as Pre-Exposure Prophylaxis (PrEP) in the United States. That decision was made because as the virus continued to mutate, now over 90% of SARS-CoV-2 variants of concerns (VOC) circulating in the U.S. are no longer believed to be neutralized by the monoclonal antibody (mAb) cocktail.

As a reminder, Evusheld is one of several monoclonal antibodies developed to attack the SARS-CoV-2 virus by attaching to its spike protein and thus preventing or treating COVID-19 infections. Evusheld and others were very successful early in the pandemic in providing effective prophylaxis and treatment.

Now there is no PreP option for CLL / SLL patients or others who are immunocompromised. There are, in fact, no effective monoclonal antibodies (mAb) authorized to prevent or treat anyone of any stage of COVID-19 infection. Evusheld was the last mAb standing.

Here is the link to the official FDA statement.

However, all is not lost.

Though still too high, hospitalizations, ICU admissions and deaths are falling dramatically for CLL / SLL.

A well-fitted N95 mask, handwashing, good ventilation, and social distancing will protect against any variants.

If one does contract COVID-19, there are several effective, readily available therapies that continue to work with all VOCs. However, remember that most of these therapies must be taken within the first few days of the diagnosis for best results.

High-Titer COVID Convalescent Plasma is another worthy treatment option for the immunocompromised.

Please complete and print out your personal COVID ACTION PLAN, so you are best prepared.

Finally, new PrEP trials are coming, including this one: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA), so we may soon have new antibodies that are active against all the circulating strains.

CLL Society is relentless in our advocacy on behalf of the CLL / SLL and other vulnerable communities with all the pharmaceutical, research, governmental and regulatory stakeholders to ensure our needs are not forgotten in the move to declare the pandemic over.