Johnson & Johnson's Tremfya garners FDA clearance for plaque psoriasis

Johnson & Johnson's Janssen Biotech unit announced that the FDA approved Tremfya (guselkumab) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The company noted that the drug "is the first and only approved biologic therapy that selectively blocks only IL-23."

According to Janssen, the FDA approval was based on results from studies that included more than 2000 patients in the Phase III VOYAGE 1, VOYAGE 2 and NAVIGATE trials. Data showed that at 16 weeks, at least seven out of 10 Tremfya-treated patients achieved at least 90 percent clearer skin, and more than 80 percent demonstrated cleared or almost cleared skin. In addition, the company noted that superior results in skin clearance were demonstrated with Tremfya compared with AbbVie's Humira (adalimumab) at weeks 16, 24 and 48.

FirstWord reports in this therapy area - KOL Insight Psoriasis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Tremfya will have a list price of $9684 per dose, or about $58 100 per year.  Janssen said that it "will work closely with payers, providers and pharmacy benefit managers to ensure Tremfya is broadly accessible and affordable for patients and that the cost for payers is competitive with currently available biologic therapies for psoriasis." The drugmaker indicated that it offers a co-pay card for patients with commercial insurance that reduces their out-of-pocket cost to no more than $5 per dose.

Janssen submitted its marketing application for Tremfya to the FDA in November last year, with the drugmaker applying a priority review voucher to the filing. Applications for the drug, which was generated using MorphoSys' HuCAL antibody library technology, have also been submitted in the EU and Japan.

Commenting on the approval, MorphoSys CEO Simon Moroney said "it is a very exciting day for all of us at MorphoSys to have the first antibody generated from our proprietary HuCAL antibody technology receive marketing approval." The executive indicated that the company expects to receive royalties on the product from Janssen for five months this year, adding "we hope to be able to say in the near future how much the royalties will amount to."

"While it was largely expected, this approval marks a turning point in Morphosys' story as it prepares to receive its first royalty stream," Berenberg analysts said. The analysts previously noted that while royalties on Tremfya payable to MorphoSys will be moderate, the drug is expected to deliver peak sales of 3.2 billion euros ($3.7 billion) in 2030.

For related analysis, see Physician Views Poll Results: Dermatologists impressed with guselkumab; US docs likely to use later in treatment paradigm versus EU5 counterparts.

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