FDA Approves New Combo Long-acting Monoclonal Antibodies for Pre-exposure Prevention
The FDA issued an emergency use authorization (EUA) for tixagevimab co-packaged with cilgavimab (Evusheld), administered together, for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals 12 years of age and older, weighing at least 40 kg (88 lb).
The new medication is authorized only for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not been recently exposed to an individual infected with SARS-CoV-2. The authorization also requires that individuals either have:
- Moderate to severely compromised immune systems due to health conditions or are taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination; or
- A history of adverse reactions to a COVID-19 vaccine and/or component of these vaccines, and therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
One dose of Evusheld, administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), might be effective for pre-exposure prevention for six months, according to clinical trial data.
The FDA’s EUA approval is based on clinical trial data in adults older than 59 years or with a prespecified chronic medical condition or at increased risk of SARS-CoV-2 infection for other reasons who had not received a COVID-19 vaccine and did not have a history of SARS-CoV-2 infection or test positive for SARS-CoV-2. The main outcome measured was whether a participant had a first case of COVID-19 after receiving Evusheld or placebo and before day 183 of the trial. Study participants who received Evusheld saw a 77% reduced risk of developing COVID-19 compared with those who received placebo—a statistically significant difference. Safety and effectiveness of Evusheld continue to be evaluated.
The FDA’s statement notes that this medication is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. It is not authorized for individuals for the treatment of COVID-19 or for postexposure prevention of COVID-19.
Evusheld is a product of AstraZeneca.