FDA approves new drug to protect babies from RSV
WINK NewsJul 17, 2023
The US Food and Drug Admin. (FDA) on Monday approved nirsevimab, an antibody treatment to protect infants from the respiratory syncytial virus (RSV), which is the leading cause of hospitalization in babies under a year old in the US.
The drug, created by Sanofi and AstraZeneca, will be sold in the US by Sanofi under the brand name Beyfortus for children born during or entering their first RSV season. Children up to two years old who remain vulnerable to severe RSV can receive another during their second season.
Though vaccines are what we're truly waiting for, this approval is a major step toward protecting children against the growing threat of RSV. As this antibody treatment will be different from the rollout of traditional childhood vaccines, the FDA and CDC are also being very cautious so as to not rush anything out prematurely. This has been a painstaking accomplishment.
Under the current US health bureaucracy, approval of some treatments such as therapeutics takes far longer than vaccines. The FDA's glacial pace for delivery of these treatments must be improved. Red tape is costing the US lives.