- Johnson & Johnson's (NYSE:JNJ) The Janssen Pharmaceutical Companies has filed a supplemental marketing application with the FDA seeking approval to use Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, to treat patients with light chain amyloidosis, a rare and potentially fatal protein folding disorder that leads to multiple organ failure.
- The filing is being reviewed under an FDA initiative called Project Orbis which allows concurrent submission and review of cancer medicine applications among international regulatory agencies.
- Darzalex Faspro is currently approved in the U.S. for five indications in multiple myeloma. Subcutaneous administration is enabled by Halozyme Therapeutics' (NASDAQ:HALO) Enhanze technology.
- SA Authors are Bullish on the company.
