Posted by Michael Wonder on 23 Aug 2018
Novimmune submits marketing authorisation application in Europe for its lead drug emapalumab
22 August 2018 - Novimmune today announced that it has successfully submitted a marketing authorisation application to the EMA seeking marketing approval for its lead compound, emapalumab for the treatment of patients with primary haemophagocytic lymphohistiocytosis.
Novimmune filed a biologics license application for emapalumab with the FDA earlier in the year and was granted priority review with a PDUFA goal date for review completion of 20 November 2018.
On 11 March 2016 the FDA granted breakthrough therapy designation to emapalumab. Three months later, the compound was declared eligible for PRIME (PRIority MEdicine) by the EMA for the treatment of primary haemophagocytic lymphohistiocytosis (HLH). In addition, on 25 August 2017 a rare paediatric disease designation was granted by the FDA for emapalumab for the treatment of primary HLH.
