Johnson & Johnson’s Janssen Biotech has won FDA approval for the plaque psoriasis candidate Tremfya™ (guselkumab), creating a potentially blockbuster-scale competitor for several recent arrivals to market in the indication.

Tremfya is indicated for adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The treatment is the first and only approved biologic designed to work by selectively blocking only interleukin (IL)-23, a cytokine shown to play a key role in plaque psoriasis.

“Addressing the need for additional safe and effective plaque psoriasis therapies has been a critical area of focus at Janssen for more than 15 years,” Andrew Greenspan, M.D., vp of medical affairs at Janssen, said in a statement.

Janssen licenses from MorphoSys the HuCAL antibody library technology used to generate the guselkumab antibody. MorphoSys CEO Simon Moroney, D.Phil., has said he expected to gain royalty payments as a result, but has not disclosed how much.

The FDA’s approval was based on data Janssen submitted from three Phase III trials assessing Tremfya in more than 2000 patients—NAVIGATE, VOYAGE 1, and VOYAGE 2.

NAVIGATE showed that patients with an inadequate response following treatment with Stelara® (ustekinumab) and who then switched to guselkumab displayed significantly greater improvements in skin clearance compared with patients who continued to receive Stelara. At week 28, 31% of Tremfya-treated patients were considered cleared or almost cleared versus 14% of Stelara-treated patients 12 weeks after randomization to continue Stelara or transition to Tremfya.

The two VOYAGE trials showed statistically significant improvement in patients following treatment with Tremfya compared with AbbVie’s Humira® (adalimumab) and placebo. At week 24, more than seven out of 10 patients treated with Tremfya reported at least 90% clearer skin compared with more than 4 in 10 patients treated with Humira.

Scaling Blockbuster Heights

Humira was last year’s top-selling drug with $16.078 billion in 2016 sales. Tremfya is not expected to reach those sales heights—analysts at Berenberg have projected annual sales of about €3.2 billion ($3.7 billion), Reuters has reported. Yet over the past two years, the plaque psoriasis segment has seen approvals of several new drugs that have cracked the billion-dollar blockbuster threshold.

One is Janssen’s anti-IL-12/23 monoclonal antibody Stelara, which last year racked up $3.232 billion in sales, up 30.6% from 2015. Another is Novartis’ Cosentyx® (secukinumab), which reached blockbuster status last year with sales of $1.1 billion.

Below blockbuster levels is Eli Lilly’s Taltz® (ixekizumab), whose market availability was announced in May 2016. Taltz generated $113.1 million in sales last year, more than half of which ($61.3 million) came during the fourth quarter. Since then, Taltz gained $96.6 million in Q1.

And this year, Valeant Pharmaceuticals International plans to launch Siliq™ (brodalumab) by positioning the product as the lowest-cost injectable biologic psoriasis treatment on the market, with a list price of $3500 per month. Siliq will also be included in the company's patient access program to further offer financial support and access to patients, Valeant said on April 21.

“For the more than one million Americans living with moderate to severe plaque psoriasis, the approval of Tremfya is a meaningful addition and offers physicians and patients an effective new, first-in-class therapy that selectively inhibits IL-23,” Michael Siegel, Ph.D., vp of research programs for the National Psoriasis Foundation, said in the Janssen statement.

Janssen won expedited regulatory review after applying an FDA Priority Review Voucher it gained through the 2012 approval of its pulmonary multidrug-resistant tuberculosis (MDR-TB) treatment Sirturo® (bedaquiline).

Janssen added that it will work with payers, providers, and pharmacy benefit managers to ensure affordability of Tremfya to patients and comparability of costs for payers with currently available biologic therapies for psoriasis. Janssen cited its patient support programs, which include a co-pay card for patients with commercial insurance that reduces out-of-pocket costs for Tremfya to no more than $5 per dose.

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