Posted by Michael Wonder on 10 Sep 2020
Halozyme announces Janssen submission for FDA approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of patients with light chain amyloidosis
10 September 2020 - Follows FDA approval of Darzalex Faspro utilising Enhanze technology in May 2020 for the treatment of patients with multiple myeloma.
Halozyme Therapeutics today announced that its collaborator Janssen has submitted a supplemental biologics license application to the U.S. FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab utilising Halozyme's Enhanze technology, for the treatment of patients with light chain amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies.
The supplemental biologics license application is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June 2020.
