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HomeBabyBabies in Ireland study supports use of Cystic Fibrosis drug from four...

Babies in Ireland study supports use of Cystic Fibrosis drug from four weeks

A new study conducted by RCSI University ​of Medicine‍ and Health Sciences and Children’s Health Ireland has found that a drug for Cystic Fibrosis, which targets the underlying defect that⁤ causes the condition,⁣ has been ⁢proven to be safe⁣ and effective in newborns who⁢ are four⁣ weeks old and older. According to one‌ of the lead researchers, ⁤this discovery​ is considered a significant milestone for Cystic Fibrosis. The ⁣study also included the participation of the first baby in ⁤the‌ world.The drug Ivacaftor,⁤ also known as Kalydeko, is the first ⁢medication specifically developed to address the underlying defect in Cystic​ Fibrosis. It was initially authorized‍ for use in⁤ adults and then gradually⁢ approved for older⁢ and⁤ younger children​ over the⁣ course of several⁤ years. Currently, it is sanctioned for infants as young as four months ⁤old, but ‌new ‍research indicates that it could be safe ​and effective⁣ for​ babies as young as four‌ weeks old. Specialists‍ in Cystic Fibrosis anticipate that starting treatment at an earlier ⁣age could potentially slow ‍down‌ or even⁤ stop the ​progression of⁤ the condition.in the treatment of Cystic Fibrosis, has shown to⁢ significantly improve lung function‍ in⁤ children, prompting international research studies led by RCSI and Children’s Health Ireland. The⁣ results of these studies‌ may lead to the possibility⁣ of administering the medication to eligible infants as soon as they ⁤are diagnosed, rather than waiting ​until they are four months old.

Paul McNally, Associate Professor of Paediatrics at RCSI and Consultant in Respiratory Medicine at CHI, described the study as a major breakthrough in the ⁣field⁢ of Cystic Fibrosis.​ The study, ‌published in ‌the Journal of Cystic‍ Fibrosis, was co-authored by⁣ McNally. “Ivacaftor has shown significant improvement in the treatment of ⁢Cystic Fibrosis over the years,⁣ and this ⁤development ⁣has the⁢ potential to greatly‍ impact the way we approach ​treatment for affected children,” ⁤McNally stated.Kalydeko has undergone clinical trials ⁢in increasingly‌ younger​ children, and ​this ​study has demonstrated its safety and effectiveness in children as young as ⁣four weeks ​old,” he noted. “This is a ​significant advancement because most children are⁢ diagnosed through newborn screening at this ⁣age. Having a treatment that addresses‍ the root cause of the disease in newborns and can be initiated immediately upon diagnosis will offer families a⁢ great deal of comfort and hope.”

Cystic Fibrosis is a genetic disease that primarily impacts the⁤ lungs and digestive system. Ireland has the highest occurrenceThe prevalence of Cystic Fibrosis in Ireland is high, with approximately 1,400‍ children and adults living​ with the condition. More than⁢ 30 ‌new cases are diagnosed each year, usually detected around 4 weeks of⁢ age‌ through the⁣ newborn screening programme. In recent years, there have been new⁢ medicines ‌developed to target the underlying defect that causes Cystic Fibrosis. ​Ivacaftor (Kalydeko)​ is one such treatment that focuses on a genetic mutation present in around 4% of people with Cystic Fibrosis globally, and about 10%⁤ in Ireland. Siblings Kara (aged 5) and ⁤Isaac Moss (aged 2) have both taken part in the study.The research ⁣was conducted through Children’s Health Ireland.⁤ Kara participated in an‍ earlier stage of the study, which led to the approval of ⁣the ⁤drug for older infants. This paved the way for the latest trial that⁤ Isaac was a part of. ​Isaac, the​ first baby in the world to be diagnosed with Cystic Fibrosis⁢ from birth, was enrolled directly ‌onto a‍ trial for these innovative treatments.

“Both Kara ‍and Isaac are ⁣currently doing⁤ very well and surprisingly are‍ not experiencing any of the⁤ typical symptoms of Cystic Fibrosis,” ‌their mother Debbie stated.

Debbie emphasized ​the importance of⁢ research ​studies like this one in ⁤ensuring that children have access to the right treatments.as early as‌ possible.⁣ With the ⁣right medications, children can have a healthy childhood ‍and⁢ look forward to ‍a brighter future”

The pharmaceutical company Vertex Pharmaceuticals ⁤manufactures Ivacaftor⁤ and is ‌currently seeking an extension to the marketing authorization for Ivacaftor for infants ⁣as young as one month old from the⁤ European Medicines Agency.