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J&J files U.S. application for expanded use of Darzalex Faspro

September 10, 2020

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.

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