Ministers from the Department of Health have written a letter asking that Vertex bring negotiations with NHS England over access to cystic fibrosis drug Orkambi “to an urgent resolution”.
European regulators have expanded the scope of Vertex’ Orkambi to include children with cystic fibrosis aged six through 11 who have two copies of the F508del mutation.
Positive CHMP opinions are recommendations for approval to the European Commission, which has the authority to approve medicines for the European Union.