The FDA voted unanimously to endorse the long-acting monoclonal antibody Beyfortus for newborns and infants.
straZeneca Plc’s and Sanofi’s drug to prevent respiratory syncytial virus won support from a U.S. regulatory panel for use in infants, potentially adding to a group of breakthrough products set to reach pharmacy shelves this year.
“The incredible importance of a disease that infects almost every child before the age of two—the impact of that disease on their families, on the children themselves, on the health-care system—all make a product like this very important,” said Douglas Diekema, a temporary advisory committee member and professor of pediatrics at the University of Washington in Seattle. “I was convinced by the efficacy data, I was reassured by the safety data.
“We are encouraged by the advisory committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said in an email. RSV is the leading cause of hospital admission for babies under the age of one, and most children catch the disease before age two. Scientists and doctors have been looking for, which also creates a large health burden in older people, for more than 60 years.
Ireland Latest News, Ireland Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Discount chain Wilko drafts in advisers ahead of rent cut talksPrivately owned Wilko has hired CBRE, the property agent, to assist its negotiations with landlords as it braces for crunch talks on rent cuts across its stores, Sky News understands.
Read more »
Scottish accent is voted 'most attractive' in the UK - full listA new study that surveyed 2,000 members of the UK public has revealed that Scottish is the nation's favourite accent, beating out Queen's English, Geordie, and more.
Read more »
I tried the chippy ECHO readers voted the best in MerseysideThe family have been in business since the 1960s
Read more »
Long Sutton housing complex proposal denied amidst overdevelopment worriesLong Sutton housing complex proposal denied amidst overdevelopment worries Lincolnshire
Read more »
Parents at two NI schools vote overwhelmingly for integrated statusParents with children at the secondary and primary School have voted in favour of the transistion
Read more »
The BABY1000 study: chasing lifetime risk factors in prenatal and early postnatal lifeThe BABY1000 study: chasing lifetime risk factors in prenatal and early postnatal life bmj_latest Sydney_Uni baby1000study riskfactors pregnancy pregnant prenatal postnatal
Read more »