The Food and Drug Administration has given the green light to a new drug to protect some of the people most at risk from Covid.
The agency granted emergency use authorization for Pemgarda, a monoclonal antibody injection, in immunocompromised people 12 years of age and older. The medicine is intended to protect against Covid for people who are unlikely to have an adequate immune response after vaccination. This includes those who have received stem cell or organ transplants and cancer patients taking drugs that suppress the immune system.
“It will be for a very small segment of Americans,” said Dr. Michael Mina, a former Harvard epidemiologist who is now the chief scientific officer for eMed, a telehealth company. But, he said, it’s a vital group to protect: the people who feel most behind at this stage of the pandemic.
“For people who are immunocompromised and literally defenseless because their immune system isn’t really working, this is really a major development,” said Dr. Ziyad Al-Aly, chief of research and development at the St. Louis Veterans Health System. .
Pemgarda will be available within the next week or two, said David Hering, CEO of Invivyd, the company that makes it. The company is still evaluating the cost of the drug, Mr. Hering said. he expects Medicare and private insurance plans to cover it.
The medicine is given as an infusion in doctor’s offices and other health care settings. it takes about an hour to complete the infusion. The most common side effects in a clinical trial included injection site reactions, cold and flu, fatigue, headaches and nausea. Four of the 623 trial participants experienced anaphylaxis, a severe allergic reaction.
The aim is to give people the drug before they are exposed to the virus, to reduce the risk of serious outcomes from Covid and reduce the chance of contracting the virus. “You think of it like vaccines,” Dr. Al-Aly explained. The drug is not a cure for those with Covid: You cannot take Pemgarda if you have the virus or have recently been exposed.
People may choose to take a dose of the drug as often as every three months, Mr. Hering said. It’s unclear whether some people will need to take additional doses of the drug indefinitely, said Dr. Joseph Bailey, a pulmonologist at Northwestern Medicine’s Comprehensive COVID-19 Center.
Pemgarda is not yet fully approved. “They haven’t made it to the finish line with their study yet,” Dr. Bailey said. The agency approved the drug based on data that measured people’s titers, a measure of antibodies, so it’s too early to gauge exactly how effective the drug will be at preventing infections in the real world.
Previous treatments with monoclonal antibodies, such as Evusheld, were taken off the market as they became less effective against new variants of Covid. The company that makes Pemgarda is preparing to target new variants as they emerge, Mr. Hering said. But it remains to be seen what will actually happen if and when the virus evolves, said Dr. Peter Chin-Hong, an infectious disease expert at the University of California, San Francisco.
However, experts are optimistic. “As long as there’s still that segment of the population that remains extremely vulnerable, the whole community really needs to be massively aware of the virus,” Dr. Mina said.