Posted by Michael Wonder on 28 Feb 2022
AbbVie seeks new indication for Imbruvica (ibrutinib) in paediatric patients with chronic graft versus host disease
28 February 2022 - The sNDA and NDA submissions were primarily based on results of three years of data from the Phase 1/2 iMAGINE clinical trial.
AbbVie today announced the submission of a supplemental new drug application to the U.S. FDA for Imbruvica (ibrutinib) for the treatment of paediatric and adolescent patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic therapy.
A new drug application was also submitted for an oral suspension formulation of Imbruvica to provide an alternative administration option for paediatric patients. If approved, this represents AbbVie's first paediatric indication for Imbruvica.
