FDA Approves First Long-Acting Drug to Protect Infants and Children Against RSV
By Matthew Perrone, The Associated Press
The Food and Drug Administration (FDA) has granted approval for the first long-acting drug that protects infants and children up to 2 years of age against the respiratory syncytial virus (RSV). This virus affects millions of adults and children in the United States each year, causing symptoms similar to a cold but can be deadly for infants, the elderly, and those with underlying health conditions.
“The approval of this drug addresses the significant need for medications that can help reduce the impact of RSV disease on children, families, and the healthcare system,” stated FDA official John Farley.
Last year, there was a surge in RSV cases, overwhelming children’s hospitals across the US with respiratory complaints. Currently, there is no vaccine available for babies, although Pfizer and other drugmakers are working on developing one.
The newly approved drug by AstraZeneca, to be marketed as Beyfortus in the United States, is a laboratory version of an antibody that enhances the immune system’s ability to fight off RSV.
With FDA approval, even premature babies can receive a single injection of Beyfortus to protect themselves during the early part of the RSV season, which typically lasts around five months. Children up to 2 years old can also receive an additional dose to safeguard them against the virus in subsequent seasons.
Sanofi, the marketing partner for Beyfortus in the United States, has not disclosed the drug’s price yet. However, it is worth mentioning that the drug is already approved in Canada, Europe, and the United Kingdom.
The FDA greenlit the drug based on three studies demonstrating a 70% to 75% reduction in the risk of RSV infection in infants and children up to 2 years old.
Next month, advisers from the Centers for Disease Control and Prevention will convene to recommend who should receive the drug.
Although a similar antibody received FDA approval over 20 years ago, it is only recommended for high-risk babies and necessitates monthly injections. Pediatricians believe that the longer-lasting effect of the AstraZeneca shot will lead to greater adoption of the drug.
In the US, approximately 58,000 children under the age of 5 are hospitalized each year due to RSV, and several hundred die as a result.
This year has seen significant progress in RSV research, with the introduction of the first vaccines against the virus. In May, the FDA approved two vaccines for seniors, developed by GlaxoSmithKline and Pfizer. Additionally, a decision is expected in August regarding Pfizer’s vaccine for pregnant women seeking to confer protection onto their babies.
This groundbreaking approval from the FDA brings hope for the prevention and management of RSV in vulnerable infants and children.