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J&J Seeks Label Expansion of Darzalex Faspro for Amyloidosis

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Janssen, a subsidiary of Johnson & Johnson (JNJ - Free Report) , announced that it has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion of Darzalex Faspro for treating patients with newly-diagnosed light chain (AL) amyloidosis, a rare and potentially serious disease. The indication currently has no approved treatment.

Darzalex Faspro is the subcutaneous formulation (SC) of J&J’s blockbuster drug Darzalex, which is approved to treat multiple myeloma (MM). Notably, the FDA and the European Commission approved Darzalex Faspro as a treatment for patients with multiple myeloma (MM) in May and June this year, respectively.

The SC formulation is developed using Halozyme’s (HALO - Free Report) ENHANZE technology.

The sBLA for amyloidosis was based on positive data from the phase III ANDROMEDA study, which evaluated SC formulation of Darzalex in combination with Velcade (bortezomib), cyclophosphamide and dexamethasone (D-VCd) versus VCd alone.

Importantly, the results from the ANDROMEDA study demonstrated Darzalex Faspro’s potential ability to modify the organ damage, which is a hallmark of this fatal disease.

The sBLA for Darzalex Faspro is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) program, leading to a more efficient review process to ensure that treatments are available for patients as soon as possible.

Meanwhile, last month, the FDA approved Darzalex in combination with Amgen’s (AMGN - Free Report) Kyprolis and dexamethasone for patients with relapsed/refractory MM as the second to fourth-line treatment option.

We note that Darzalex is a key drug in J&J’s portfolio. Sales of the drug rose 31% to $1.8 billion in the first six months of 2020. A further label expansion of the drug will boost its sales in the future.

Shares of J&J have inched up 0.7% so far this year compared with the industry’s rise of 0.5%.


In a separate press release, J&J announced that Health Canada nodded to a label expansion of its blockbuster IL-23 inhibitor Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA). The drug can be used as a monotherapy or in combination with conventional DMARDs (Disease Modifying Anti-Rheumatic Drugs) for the given patient population.

The drug is already approved in the United States, Canada, Japan and Brazil for the treatment of adult patients with active PsA.

Notably, Tremfya is approved for addressing adult patients with moderate-to-severe plaque psoriasis and is the first drug in its category to receive a nod for treating both active PsA and moderate-to-severe plaque psoriasis.

Zacks Rank & Key Pick

J&J currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large-cap pharma sector is GlaxoSmithKline plc (GSK - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Glaxo’s earnings estimates have been revised 3.8% and 4.4% upward for 2020 and 2021 each over the past 60 days.

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