FDA Authorizes COVID Drug Pemgarda for High-Risk Patients

The Food and Drug Administration (FDA) granted an emergency use authorization (EUA) to a medicine meant to protect certain immunocompromised people against COVID-19.

The medicine, pemivibart (brand name Pemgarda™), is for people who are at least 12 years of age, weigh more than 88 pounds, and are moderately to severely immunocompromised.

An EUA is a tool the FDA uses to expedite the availability of drugs, vaccines, and other products during a public health emergency. While the public health emergency for COVID officially expired in May 2023, the FDA can still issue EUAs related to it.

“This medication provides important protection for the immunocompromised, a population that is more likely to have serious COVID illness and a higher mortality rate,” says Scott Roberts, MD, a Yale Medicine infectious diseases specialist.

Being immunocompromised means your immune system doesn’t work as well as it should to protect against infection because of a medical condition, such as cancer, that weakens immune function or because you receive medicines or treatments, such as immunotherapy, that suppress the immune system.

“The population identified as moderately to severely immunocompromised includes solid organ transplant recipients, stem cell transplant recipients, and those who are on chemotherapy for cancers such as lymphoma and leukemia, among many others,” Dr. Roberts explains. (The Centers for Disease Control and Prevention (CDC) provides a more detailed list.) Approximately 3% of adults in the United States are immunocompromised.

“This group is also less likely to build enough protection against COVID after vaccination. For these patients, the pandemic is not over,” says Dr. Roberts. “Hopefully, this new treatment will help the vulnerable feel safer.”

Below, we talk more about Pemgarda with Dr. Roberts.

Those who are not immunocompromised most likely have a strong mix of “hybrid” immunity to COVID at this point, both from vaccination and natural infection, Dr. Roberts explains.

“Most people should not be concerned when a new COVID variant arises because even if it bypasses some of their protection, it's not going to bypass all of it,” Dr. Roberts says. “But some immunocompromised people do not have that luxury. Any COVID infection is going to hit them the hardest. And vaccination is still the best tool we have to offer for the prevention of severe COVID.”

However, this drug is a new tool that can help immunocompromised patients feel safe going about daily activities as many other people do at this phase of the pandemic, he adds.

Pemgarda is a type of medicine called pre-exposure prophylaxis (PrEP), which is taken to prevent COVID infection. Anyone with COVID—or who has a known recent exposure to someone with a COVID infection—cannot take Pemgarda.

Paxlovid and Remdesivir, conversely, are meant to be taken after a known COVID infection and are for anyone deemed high-risk for serious illness, including those who are immunocompromised.

Pemgarda is a type of monoclonal antibody (mAb), a drug therapy that uses antibodies made in a laboratory. These antibodies attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19, and prevent the virus from entering the body’s cells.

“Despite vaccination, many immunocompromised patients are still unable to generate the antibodies necessary to block this entry; Pemgarda serves as a tool to increase SARS-CoV-2-specific antibodies to levels seen in nonimmunocompromised individuals after vaccination,” says Dr. Roberts.

It is given as an infusion in a medical setting and takes about an hour to complete. Patients can get a dose of the medication as often as every three months.

A previous mAb treatment, Evusheld™, was authorized by the FDA in 2021 to prevent COVID in immunocompromised patients. However, the medication proved ineffective against newer COVID variants and was taken off the market in January 2023.

Pemgarda is the only COVID PrEP drug on the market.

Pemgarda was granted an EUA based on data from an ongoing Phase 3 CANOPY clinical trial, as well as efficacy data from previous clinical trials of adintrevimab, the parent mAb for pemivibart, and other monoclonal antibody products.

In trials, adintrevimab was associated with an approximate 70% risk reduction of developing symptomatic COVID-19 compared to a placebo, according to Invivyd, the company that makes the drug. The CANOPY studies were done when the JN.1 subvariant was circulating. JN.1 is still the predominant coronavirus subvariant.

In the trial, 623 participants received at least one dose of the drug. The most common side effects included skin reactions at the infusion site, cold and flu-like illness, headache, fatigue, and nausea. Four people experienced anaphylaxis (a severe allergic reaction).

“For patients who are worried about the trade-off, I think it requires a risk-benefit analysis,” says Dr. Roberts. “I think in most cases the benefit is going to outweigh the risk of anaphylaxis, especially if doctors can mitigate it by having medications such as an Epi-pen there in case a patient does have a severe allergic reaction.”

Immunocompromised people who are interested in taking Pemgarda should talk to their doctor. “It might be better for some patients to talk to a specialist first—for instance, if an individual has cancer, it might be best for them to talk to their oncologist about whether this drug is right for them,” Dr. Roberts advises.

The medication is expected to be available in April. The price has not yet been set, but Medicare and private insurance plans are expected to cover it, according to news reports.