Food and Drug Administration approved on Monday Mercks aims to Protecting babies From respiratory syncytial virus in the first season of the virus, pushing competitors to competitors. Sanofi and AstraZeneca.
this Decide The company will be allowed to launch the drug, which will be sold in the form of ENFLONSIA before the RSV season, which usually starts around the fall and winter and continues into the spring. Merck said in a press release that it expects the shooting to begin in July, before the virus begins to spread widely.
The approval provides doctors with a new treatment option that causes the death of older Americans, hundreds of deaths each year. Complications of RSV are the main cause of neonatal hospitalization.
“We are committed to ensuring that we are available in the United States before the upcoming RSV season begins to help alleviate the significant burden of this widespread seasonal infection to the home and health care system,” Dr. Dean Li, president of Merck Research Laboratories, said in a press release.
Merck’s shots will compete with similar blockbusters from Sanofi and Astrazeneca, called Beyfortus, which has a short supply nationwide in the 2023 RSV season due to unprecedented demand.
Both are prophylactic monoclonal antibodies that deliver the antibodies directly into the blood for immediate protection. But everyone targets different parts of the virus, so it’s hard to compare them directly.
Regardless of weight, Merck’s treatment can be performed for babies, which the company says may facilitate in terms of dosing. Meanwhile, the recommended dose of Beyfortus is based on the baby’s weight.
Sanofi Monday reveal Active efforts to increase Beyfortus supply include plans to start shooting in the early third quarter. Last year, Beyfortus booked 1.7 billion euros ($1.8 billion) in sales.
US RSV vaccines can also be provided in the United States Pfizer,,,,, gsk and Modern. But these lenses are only used in adults or pregnant women. Recently, the FDA Pause test While evaluating safety issues, RSV shooting of toddlers.
All companies on the market are awaiting an external vaccine consultant meeting from June 25 to 27 to meet with the CDC, when they will constitute recommendations for RSV shooting and other immunizations.
In a late-stage trial of ENFLONSIA, treatment reduced RSV-related hospitalizations by more than 84%, reduced hospitalizations due to lower respiratory tract infections by 90%, and reduced hospitalizations for its placebo in five months by 90%. The lens also reduced lower respiratory tract infections that require medical treatment by more than 60% compared to placebo to five months.
RSV is a common cause of lower respiratory tract infections (such as pneumonia).
