Posted by Michael Wonder on 26 Apr 2022
Pharming receives Promising Innovative Medicine designation for leniolisib from UK MHRA
26 April 2022 - A Promising Innovative Medicine designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme.
Pharming announces that it has received a positive decision from the UK's MHRA on a Paediatric Investigation Plan submission for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, for the treatment of activated phosphoinositide 3-kinase delta syndrome in patients from 1 year of age to less than 18 years of age.
The Company also announces that the MHRA has granted Promising Innovative Medicine designation to leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome.
