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Food and Monday Administration approved Merk ‘s shot intended for Protect babies From the respiratory virus syncytial virus during the first season of the virus, bringing the market competitor for similar treatment Sanfi and Astrazeneca.
A decision Allow the company to launch the drug, which will be sold as Enflonsia, ahead of the RSV season, which usually starts around the fall and winter and lasts in the spring. Merke said in the release that he expected the orders that began in July, while deliveries were delivered before the virus began to spread widely.
Approval gives doctors a new variant of treatment of the virus, which causes thousands of deaths among elderly Americans and hundreds of deaths among infants every year. RSV complications are the main cause of hospitalization among newborns.
“We strive to provide the presence (Enflonsia) in the US before the start of the future RSV season to help reduce a significant load of this extensive seasonal infection on families and health care systems,” the President of the Merck’s research laboratory said.
The prime shot will compete with the same blockbuster treatment with Sanofi and Astrozenka called Beyfortus, which was insufficient across the country during the RSV 2023 season from unprecedented demand.
Both are preventive monoclonal antibodies that deliver antibodies directly into the blood to ensure immediate protection. But everyone is aimed at another part of the virus, which makes them directly compared.
Merck treatment can be administered to babies regardless of their weight, which, according to the company, can offer convenience in terms of dosage. Meanwhile, the recommended dosage of Beeform is based on the baby’s body weight.
Sanofi on Monday disclosed Aggressive efforts to increase the delivery of Beeform, including the plan to start delivery at the beginning of the third quarter. Last year, BeyFortus booked a 1.7 billion euro (1.8 billion dollars).
Vaccines for RSV are also available in the US from companies such as Pfizer. Gsk and Modern. But these pictures are only intended for use in adults or pregnant women. Recently FDA stop testing Shooting RSV in young children while it evaluates security problems.
All companies in the market are waiting for a meeting of advisers on vaccine street in the Center for Disease Control and Prevention from June 25 to June 27, if they will form recommendations for RSV shots and other vaccinations.
In the middle and late stage of the test on Enflonsia, treatment reduced hospitalization associated with RSV by more than 84% and reduced hospitalization due to low respiratory infections by 90% compared to infants over five months. The impact also reduced the infections of the lower respiratory tract that requires medical care by more than 60% compared to placebo for five months.
RSV is a common cause of infections of the lower respiratory tract such as pneumonia.
