US regulators have issued a green light for Janssen Biotech’s new biologic Tremfya to treat moderate to severe plaque psoriasis.
Tremfya (guselkumab) is the first and only biologic approved that selectively blocks interleukin (IL)-23, a cytokine that plays a key role in plaque psoriasis.
The drug’s approval came on the back of clinical trial data showing that, at 16 weeks, at least seven out of ten Tremfya patients achieved at least 90 percent clearer skin, and more than 80 percent showed cleared or almost cleared skin.
Also, Tremfya-treated patients who achieved PASI 90 at week 28 maintained that response at week 48, while at week 24, more than seven out of ten patients treated with Janssen’s drug reported at least 90 percent clearer skin compared with more than four out of ten patients treated with Humira (adalimumab).
"Living with plaque psoriasis is challenging, especially the constant pain, itching and burning," said Patti Janick, a guselkumab clinical trial participant. "I am encouraged by the results I've experienced with Tremfya and the possibility it offers others living with plaque psoriasis to find similar relief and clearer skin."
Janssen said it will now 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 drug will compete for market share with Novartis’ Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab) and Valeant’s Siliq (brodalumab), but these all inhibit IL-17.
European regulators are currently reviewing Tremfya for psoriasis after a submission was filed in November last year.