J&J's (JNJ) Darzalex Faspro Gets FDA Nod for Amyloidosis

Janssen, a subsidiary of Johnson & Johnson JNJ, announced that the FDA has granted accelerated approval to its supplemental biologics license application (sBLA), seeking approval of Darzalex Faspro (called Darzalex SC in EU) for a new indication. Following the approval, the drug is now approved in combination with bortezomib, cyclophosphamide and dexamethasone for treating newly diagnosed light chain amyloidosis (AL) in adult patients.

The drug is the first and only approved treatment for this rare blood cell disorder, which can lead to the deterioration of vital organs, most notably the heart, kidneys and liver.

Please note that Darzalex Faspro is the subcutaneous formulation (SC) of J&J’s blockbuster drug Darzalex, which is approved to treat multiple myeloma (MM). Notably, Darzalex Faspro is approved as monotherapy or in combination regimen for treatment of patients with MM in different treatment settings. Meanwhile, the company is seeking another label expansion of Darzalex Faspro in combination with Celgene’s CELG Pomalyst (pomalidomide) and dexamethasone for treating patients with relapsed or refractory MM in second or later-line setting.

We note that Darzalex is approved as an intravenous formulation. Janssen in-licensed Darzalex from Genmab GMAB in 2012. The SC formulation of Darzalex, Darzalex Faspro is developed using Halozyme’s HALO ENHANZE technology.

The FDA approval of Darzalex Faspro for amyloidosis indication is based on positive data from the phase III ANDROMEDA study, which demonstrated Darzalex Faspro’s potential ability to modify the organ damage, which is a hallmark of this fatal disease. Among the patients receiving Darzalex Faspro combo, 42% achieved hematologic complete response rate compared to 13% in the comparator arm.

Please note that continued approval in AL indication for Darzalex Faspro is subject to verification and description of clinical benefit in a confirmatory trial. Moreover, the drug is not recommended for AL patients with NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB.

Shares of J&J have gained 7.5% in the past year compared with the industry’s rise of 4.1%.

We note that Darzalex is a key drug in J&J’s portfolio. Sales of the drug rose 36% to almost $3 billion in the first nine months of 2020. The subcutaneous formulation of the drug significantly reduces administration time from several hours to 3-5 minutes, providing a better option for patients. A potential approval of Darzalex Faspro for all approved indications of Darzalex will likely lead to higher sales as more patients may choose the drug for their treatment due to convenient administration.

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