The European Commission approved Sanofi and AstraZeneca's respiratory syncytial virus preventive drug Nov. 4 while the U.S. faces a surge and a lack of RSV treatments.
Europe is the first regulatory organization to approve the product, Beyfortus (nirsevimab), which is the first and only RSV protective option for the broad infant population, AstraZeneca said in a news release.
A Sanofi spokesperson told CNN it has submitted an application for the monoclonal antibody treatment to the FDA with the hopes to have it available in next year's RSV season.
This year's season started earlier and is more intense than expected, with some children's hospitals reporting a 300 percent increase in admissions and one Texas hospital checking in a pediatric patient every 2.5 minutes.
In the U.S., the generic palivizumab is an approved preventive therapy for preterm babies who are 6 months and younger, and children 2 years and younger who are born with a chronic lung condition and some heart diseases. For the rest of the young population, though, supportive care such as providing oxygen and IV fluids is the only option.
Six drugmakers are racing to test and gain approval for their RSV vaccines, with Pfizer and Sanofi and AstraZeneca leading.