FDA approves Darzalex Faspro
On May 1, the US Food and Drug Administration approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma, marking the first approval for this innovative subcutaneous formulation globally and providing a must faster form of administration.
This new product, from US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech, allows for subcutaneous dosing of daratumumab, marketed as Darzalex. J&J’s shares closed up 1.12% at $148.29 on Friday.
Janssen was granted an exclusive worldwide license to develop, manufacture and commercialize daratumumab by Denmark’s Genmab (Nasdaq: GMAB) in August 2012. Darzalex is already a blockbuster seller for the US company, having generated first quarter 2020 sales of $937 million, up 49% from the like, 2019 quarter.
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