EU and UK have Authorised Nova’s SCD Complications Drug

The hereditary condition is brought on by genetic abnormalities that disrupt haemoglobin synthesis. 

The Medicines and Healthcare Products Regulatory Agency and the European Commission have signed off Nova Laboratories’ Xromi to treat babies as young as nine months old with vaso-occlusive consequences of sickle cell disease (SCD). 

Deputy managing director of Nova Laboratories stated: ‘’Approval to extend the indication to infants has the potential not only to alleviate the immediate symptoms but to significantly improve long-term outcomes and quality of life for those born with this genetic disorder.” 

  “The results of the HUPK study, as well as a robust body of evidence from multiple studies conducted over the past decade, demonstrate Xromi’s efficacy in reducing complications associated with SCD, not just in adults and older children but also in infants.” Stated the professor of paediatric haematology ar Guy’s and St Thomas’ Hospital.  

Xromi had been authorised in the UK and EU in 2019 for mitigating the vaso-occlusive consequences of SCD for individuals above the age of nine months and was subsequently approved by the Scottish Medicines Consortium in 2020 to treat kids aged two to nine.