Latest news with #Enflonsia
Yahoo
6 hours ago
- Health
- Yahoo
US FDA approves Merck's RSV antibody for infants
(Reuters) -The U.S. Food and Drug Administration on Monday approved Merck's preventive antibody shot to protect infants up to one year of age from respiratory syncytial virus during their first RSV season, the company said. The United States has seen limited supply of Sanofi and AstraZeneca's antibody Beyfortus, the only preventive shot for RSV available in the country for infants and toddlers so far. Merck's therapy, called clesrovimab and branded as Enflonsia, is a monoclonal antibody that can be administered as a single dose regardless of birth weight in healthy pre-term, full-term and at-risk infants to protect them against mild, moderate and severe RSV. RSV is a common respiratory virus that causes seasonal infections such as the flu, but is a leading cause of pneumonia and death in infants and older adults. The approval was based on results from a late-stage trial in which Enflonsia had a comparable safety profile to Swedish Orphan Biovitrum's Synagis, a monthly injection. Merck said that Enflonsia is the first and only RSV preventive option administered to infants using the same dose regardless of weight, and it told Reuters the drug will be priced at $556 per dose. Jefferies analyst Akash Tewari said last year that this is beneficial since physicians have to forecast an infant's potential weight during RSV season with Beyfortus, which makes dose ordering and inventory more complex. In the U.S., an estimated 58,000–80,000 children younger than five years are hospitalized due to RSV each year, according to the U.S. Centers for Disease Control and Prevention. The CDC currently recommends two immunization options for babies to be protected from severe RSV — an RSV vaccine given to the mother during pregnancy or an RSV antibody given to the baby. Merck expects the drug's shipments to arrive in time for the 2025-2026 RSV season. The CDC's Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Enflonsia in infants.
CNBC
6 hours ago
- Health
- CNBC
FDA approves Merck's RSV shot for infants, ramping up competition with Sanofi and AstraZeneca
The Food and Drug Administration on Monday approved Merck's shot designed to protect infants from respiratory syncytial virus during their first season of the virus, bringing to market a rival to a similar treatment from Sanofi and AstraZeneca. The decision will allow the company to launch the drug, which will be marketed as Enflonsia, ahead of the RSV season that typically kicks off around fall and winter and lasts through the spring. Merck said in a release that it expects orders for the shot to begin in July, with shipments delivered before the virus starts to spread widely. The approval gives doctors a new treatment option for the virus, which causes thousands of deaths among older Americans and hundreds of deaths among infants each year. Complications from RSV are the leading cause of hospitalization among newborns. "We are committed to ensuring availability of [Enflonsia] in the U.S. before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems," Dr. Dean Li, president of Merck Research Laboratories, said in a release. Merck's shot will compete against a similar blockbuster treatment from Sanofi and AstraZeneca called Beyfortus, which was in short supply nationwide during the 2023 RSV season due to unprecedented demand. Both are preventative monoclonal antibodies, which deliver antibodies directly into the bloodstream to provide immediate protection. But each targets a different part of the virus, making it difficult to compare them directly. Merck's treatment can be administered to infants regardless of their weight, which the company said may offer convenience in terms of dosing. Meanwhile, the recommended dosage of Beyfortus is based on an infant's body weight. Sanofi on Monday revealed an aggressive effort to increase supply of Beyfortus, including a plan to begin shipping the shot early in the third quarter. Last year, Beyfortus booked sales of €1.7 billion ($1.8 billion). Vaccines for RSV are also available in the U.S. from companies such as Pfizer, GSK and Moderna. But those shots are only for use in adults or in pregnant women. Recently, the FDA paused testing of RSV shots in young children while it evaluates safety concerns. All of the companies in the market are waiting for a meeting of outside vaccine advisors to the Centers for Disease Control and Prevention from June 25 to 27, when they will form recommendations for RSV shots and other immunizations. In the mid- to late-stage trial on Enflonsia, the treatment reduced RSV-related hospitalizations by more than 84% and decreased hospitalizations due to lower respiratory infections by 90% compared with a placebo among infants through five months. The shot also reduced lower respiratory infections that required medical attention by more than 60% compared with a placebo through five months. RSV is a common cause of lower respiratory tract infections such as pneumonia.
Yahoo
6 hours ago
- Health
- Yahoo
US FDA approves Merck's RSV antibody for infants
(Reuters) -The U.S. Food and Drug Administration on Monday approved Merck's preventive antibody shot to protect infants up to one year of age from respiratory syncytial virus during their first RSV season, the company said. The United States has seen limited supply of Sanofi and AstraZeneca's antibody Beyfortus, the only preventive shot for RSV available for infants and toddlers so far. Merck's therapy, called clesrovimab and branded as Enflonsia, is a monoclonal antibody that can be administered as a single dose regardless of birth weight in healthy pre-term, full-term and at-risk infants to protect them against mild, moderate and severe RSV. RSV is a common respiratory virus that causes seasonal infections such as the flu, but is a leading cause of pneumonia and death in infants and older adults. Each year in the United States, an estimated 58,000–80,000 children younger than five years are hospitalized due to RSV, according to the U.S. Centers for Disease Control and Prevention. The CDC currently recommends two immunization options for babies to be protected from severe RSV — an RSV vaccine given to the mother during pregnancy or an RSV antibody given to the baby. Merck expects the drug's shipments to arrive in time for the 2025-2026 RSV season. The CDC's Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Enflonsia in infants.
