Afinitor everolimus regulatory update

The European Commission granted Orphan Drug designation for Novartis' Afinitor everolimus to treat tuberous sclerosis (TS). An sNDA for Afinitor to treat subependymal giant cell astrocytomas (SEGA) associated with TS is under Priority Review by FDA, with a decision expected by year end (see BioCentury, July 19). ...