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FDA authorizes new drug to protect high-risk patients against Covid

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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 infusion, in immunocompromised people ages 12 and older. The drug is intended to protect against Covid people who are not likely to develop an adequate immune response after vaccination. This includes people who have received a stem cell or organ transplant and cancer patients who take medications that suppress the immune system.

“This will affect a very small portion of Americans,” said Dr. Michael Mina, a former Harvard epidemiologist and now chief scientific officer of eMed, a telehealth company. But, he added, this is a vital group to protect: the people who feel most left behind at this point in the pandemic.

“For people who are immunocompromised and literally helpless because their immune system doesn’t really work, this is a really important development,” said Dr. Ziyad Al-Aly, head of research and development at the Veterans Affairs of St. Louis. .

Pemgarda will be available within a week or two, said David Hering, chief executive 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 drug is administered as an infusion in doctors’ 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 infusion site reactions, cold and flu-like illness, fatigue, headache, and nausea. Four of the 623 trial participants suffered anaphylaxis, a serious allergic reaction.

The aim is to give the drug to people before they encounter the virus, to reduce the risk of serious outcomes from Covid and reduce the risk of contracting the virus. “We think of it like vaccines,” explained Dr. Al-Aly. The medicine is not a treatment for those who have Covid: you cannot take Pemgarda if you currently have the virus or have been recently exposed to it.

People can choose to receive a dose of the drug as often as every three months, Mr. Hering said. It’s unclear whether some people will need to receive additional doses of the drug indefinitely, said Dr. Joseph Bailey, a pulmonologist at the Northwestern Medicine Comprehensive COVID-19 Center.

Pemgarda is not yet fully approved. “They haven’t crossed the finish line of their study yet,” Dr. Bailey said. The agency authorized the drug based on data assessing people’s titers, a measure of antibodies, and so it is too early to assess exactly how effective the drug is in preventing infections in the real world.

Previous monoclonal antibody treatments, like Evusheld, were taken off the market because they became less effective against new Covid variants. 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 specialist at the University of California, San Francisco.

Yet experts remain hopeful. “As long as there is this segment of the population that remains very vulnerable, the entire community needs to be fully aware of the virus,” Dr. Mina said.

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