The FDA revokes authorization of a key anti-COVID drug, a blow to vulnerable Americans

The Food and Drug Administration has withdrawn its provisional support for the use of evoshielda drug that was once a valuable tool for preventing patients with compromised immune systems from becoming severely ill with COVID-19.

With new viral variants increasingly adept at defeating Evusheld, the… The FDA said Biological medicine should not be used.

The FDA’s decision marks the end — at least for now — of a drug that has helped restore some normalcy to cancer patients, transplant recipients and others who weren’t vaccinated against COVID-19 or whose immune systems failed to mount a good response to the vaccine. as many as possible 3% of the US population – 7.2 million adults – are believed to have an immune deficiency that puts them at risk of severe illness or death if they contract the pandemic virus.

“It’s a really sad time,” he said. Dr. Camille Cotton, an infectious disease physician at Massachusetts General Hospital who cares for people who are immunocompromised. For her patients, she said, “It was like telling them the seat belts in your car won’t work anymore, and we won’t be able to replace them with anything.”

In recent months, nine new sub-variants of the dominant Omicron race have proven capable of slipping around Evusheld’s defenses. Collectively, those sub-variants pose now More than 90% of the samples of the SARS-CoV-2 coronavirus circulating in the United States, according to the Centers for Disease Control and Prevention.

The result: After 15 months in the nation’s weapons museum against COVID-19, it was medicine that American taxpayers spent At least $1.58 billion development and production has become largely inefficient. However, the US Food and Drug Administration said its licensing of the drug will resume if at least 10% of coronavirus samples in circulation are susceptible to infection in the future.

Evusheld is the brand name for an AstraZeneca drug that combines two monoclonal antibodies, tixagevimab and cilgavimab. in statment The British-Swedish pharmaceutical giant said on Friday that it is testing the safety and efficacy of a new antidote drug to protect people with weakened immune systems, which it hopes will take effect in the latter half of 2023.

When Evusheld became available to patients just over a year ago, its protection allowed many immunocompromised patients to come out of isolation for the first time since the pandemic began.

It was expected to be given to patients who needed it every six months. But some didn’t get the first shot, and many didn’t get a second, before changes in the coronavirus rendered it ineffective.

“We are mourning the official death of what was a really good instrument,” said Cotton.

Many doctors had already accepted that EvoShield’s time had passed.

Doctors at UCLA Medical Center and its satellites stopped giving it to transplant and chemotherapy patients in December. That’s when an Omicron variant known as BQ.1.1, which found a way to circumvent Evusheld’s protection, became mainstream across Southern California.

“It’s unfortunate,” said the UCLA infectious disease doctor. Dr. Tara Vijayan. But, she added, “we were surprised that the FDA waited so long to withdraw it.”

Thanks to the relentless rate at which new coronavirus variants are emerging, a host of bioengineered COVID-19 drugs are emerging. Monoclonal antibodies Outdated.

Since November 2020, when the first treatments for COVID-19 won temporary support from the Food and Drug Administration, six treatments have been rendered useless by genetic changes in the coronavirus. It started with the introduction of the Delta variant in March 2021, and the arrival of the Omicron variant nine months later – which is the same splinter to 18 variants – wiped out the rest.

Since April 2021, the FDA withdrawn Emergency Use Authorization for all monoclonal antibody therapies used as treatments for COVID-19 except tocilizumabwhich is still used in some hospitalized patients.

As UCLA doctors watched one monoclonal antibody treatment after another fail, “we’ve always advised caution,” said Vijayan, medical director of the Adult Antimicrobial Oversight Health System. “We were always waiting for the variables and the resistance that would come with them.”

The virus’s victory over these cutting-edge therapies has left a dwindling stock of rescue drugs for all COVID-19 patients. But for patients with weakened immunity, the situation is even worse.

The constant morphing of the virus has destroyed the storehouse of effective medicines that could save them from severe illness or death with COVID-19. Not many people can take antivirals Paxlovid Because it interacts with their other medications. This leaves them with less effective antiviruses Molinopiravir and drugs remdesivirwhich must be soaked daily – usually in the hospital – over a period of three days.

Scarcity of medicines available for patients with weakened immune systems renewed interest In convalescent plasma, an older version of antibody therapy explore it for the first time In the early days of the epidemic. As COVID-19 treatments for these fragile patients dwindle, many medical societies have recommended a return to the use of blood products from previously infected patients who have recovered.

It was posted recently Systematic review Clinical trials indicate that convalescent plasma can help prevent death in hospitalized COVID-19 patients who are immunocompromised. A British clinical trial is currently testing the use of ‘Vax-Plasma’ – plasma from vaccinated people who developed a superinfection and then recovered.