GMAB - GMAB's therapy for AL amyloidosis receives FDA approval

Genmab A/S (GMAB) has announced that the FDA has approved DARZALEX FASPRO® to treat newly diagnosed Light-chain (“AL”) amyloidosis, a rare disease affecting an estimated ~3,000 to 4,000 individuals in the U.S. annually.Janssen Biotech, Inc. (Janssen) of Johnson & Johnson (JNJ), which received the worldwide exclusive rights to develop, manufacture, and commercialize the therapy from Genmab in 2012 has submitted the supplemental Biologics License Application (sBLA) in September.Based on the Phase 3 ANDROMEDA (AMY3001) study, the approval for DARZALEX FASPRO, a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide, and dexamethasone (“VCd”), is the first and only FDA-approved treatment for the indication.Genmab expects that the milestone payment of $30M in connection with the first commercial sale of DARZALEX FASPRO in this indication will quickly occur after approval and will reflect in Genmab’s 2021 guidance.Genmab gets 15-20% royalty from worldwide sales of DARZALEX, wrote Seeking Alpha contributor Avisol Capital Partners in

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GMAB’s therapy for AL amyloidosis receives FDA approval