More than a year after the FDA yanked away authorization from Evusheld, a monoclonal antibody treatment for COVID-19, the agency granted emergency use authorization to a new COVID-19 preventive drug March 22.
The medication, Pemgarda, is a monoclonal antibody that targets the SARS-CoV-2 spike protein, and it is indicated for patients 12 and older. The authorization is not an approval, meaning the FDA greenlit the medicine "based on a reasonable belief that the product may be effective based on the best evidence available at the time," its website says, "without waiting for all the information that would be needed for an FDA approval."
Evusheld, the last authorized COVID-19 therapy, was pulled in January 2023 after being on the market since December 2021 because it was found ineffective against 90% of then-circulating variants.
Four things to know about Pemgarda:
1. Pemgarda (pemivibart) is an injectable manufactured by Massachusetts-based Invivyd. For the first dose, 4,500 milligrams are administered for at least an hour, and repeat doses of the same quantity are administered every three months.
2. The authorization is limited to patients who are immunocompromised because of a medical condition, or those who are taking immunosuppressive medications and are unlikely to be protected with a COVID-19 vaccine, according to its label.
"For people who are immunocompromised and literally defenseless because their immune system doesn't really work, this is really an important development," Ziyad Al-Aly, MD, chief of research and development at the VA St. Louis Health Care System, told The New York Times.
It will be a small pool of eligible patients, experts told the Times.
3. In an ongoing phase 3 trial, the "calculated serum neutralizing antibody titers against JN.1" matched efficacy data for other monoclonal antibody products, Invivyd said in a news release.
Side effects include hypersensitivity, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache and nausea; and its warning label lists anaphylaxis and cross-hypersensitivity with COVID-19 vaccines.
4. David Hering, CEO of Invivyd, told the Times the company has not yet decided on a price, but he expects Medicare and private insurers to cover the therapy. To evade Evusheld's footsteps, Mr. Hering said the drugmaker is working to target new variants as they evolve.