FDA agrees to Merck RSV for infant divorce to compete

The Food and Drug Administration agreed on Monday MerkS shot of designed for Infant Protection From the virus of the Mixed respiratory system during its first season of the virus, they bring to a competitor for a similar treatment Sanovi and Astrazeneca.

the resolution The company will be allowed to launch the medicine, which will be marketed as Enflonsia, before the RSV season, which usually starts in the fall and winter and continues during the spring. Merck said in a statement that he expected the shot to start in July, with the delivery of shipments before the virus started widely.

Approval gives doctors a new option to treat the virus, which causes thousands of deaths between the older Americans and hundreds of deaths between infants every year. Complications from RSV are the main cause of hospital treatment among newborns.

“We are committed to guaranteeing the availability of (Enflonsia) in the United States before the start of the upcoming RSV season to help reduce the great burden of this seasonal infection on a large scale on families and healthcare systems,” said Dr. Dean Lee, head of Merck Labs.

Merck’s shot will compete for a similar treatment from Sanofi and Astrazeneca called Beyfortus, which was in a deficiency throughout the country during the RSV 2023 season due to unprecedented demand.

Both are monotheistic antibodies, which provide direct antibodies to the bloodstream to provide immediate protection. But everyone targets a different part of the virus, making it difficult to compare it directly.

Merck shot can be given to the infants regardless of their weight, which the company said may provide comfort in terms of doses. Meanwhile, the recommended dose of Beyfortus is based on the weight of the infant’s body.

Sanofi on Monday open Adian effort to increase the offer from Beyfortus, including a plan to start charging the shot early in the third quarter. Last year, beyfortus booked sales of 1.7 billion euros ($ 1.8 billion).

RSV vaccines are also available in the United States from companies such as companies Vizarand GSK and accident. But these shots are intended for use only in adults or pregnant women. Recently, the Food and Drug Administration Temporary test RSV shots in young children while assessing safety concerns.

All companies in the market are awaiting a meeting of the external vaccine consultants to the centers of diseases control and prevention from June 25 to 27, when the recommendations of RSV shots and other immunization are formed.

In the medium to the late Enflonsia, the snapshot of the RSV hospitals has reduced more than 84 % and hospitals decreased due to 90 % decreased respiratory infections compared to the imaginary drug between infants within five months. The snapshot was also reduced by low respiratory infections that require more than 60 % medical interest compared to the imaginary drug within five months.

RSV is a common cause of lower respiratory infections such as pneumonia.