Drug Development, FDA

J&J gets a quick FDA OK for its blockbuster psoriasis contender guselkumab

Just four months after rolling out its last batch of promising late-stage data, J&J has scored a quick OK for guselkumab as a new treatment for psoriasis, one of the top drug prospects in the industry’s late-stage pipeline.

The IL-23 drug will now be commercialized as Tremfya, says the pharma giant, which tapped this drug as one of its most important Phase III products. To get the OK this fast, J&J says it used a priority review voucher, an incentive that’s become a pricey commodity in the biopharma market as developers turn to them for slash 4 months off the FDA’s review process.

EvaluatePharma recently tapped the peak sales prospects for this drug at about $1.6 billion, making it a top 20 drug. The approval is also great news for Morphosys. J&J licensed their HuCAL antibody library technology to generate the guselkumab antibody. Morphosys gets a milestone as well as a royalty rate on this, but a J&J spokesperson says that they remain undisclosed per the original deal.

J&J is late to the anti-inflammatory drug party, but the company and a long lineup of analysts believe that this drug is a prime candidate for blockbuster status after reviewing some stellar outcome data from two Phase III trials. J&J decided to use a priority review voucher it obtained with the approval of Sirturo, a treatment for multidrug resistant tuberculosis, according to a spokesperson for the company.

As we saw in the first Phase III, VOYAGE 1, guselkumab handily outscored a placebo on two measures of complete or near-complete skin clearance in VOYAGE 2. And once again their IL-23 drug slapped aside Humira, with guselkumab versus adalimumab achieving an IGA 0/1 score of 84% versus 67.7% and a PASI 90 of 70% compared to 46.8%, respectively.

Novartis’ Cosentyx got out ahead of this new wave of drugs 22 months ago, which the Swiss pharma giant has followed with 4-year data tracking a solid success — 43.5% — in keeping skin cleared over the long haul. Eli Lilly backed its new drug Taltz in a major campaign last fall. And then Valeant ambled across the finish line with brodalumab — now dubbed Siliq — a few months ago. Their drug, picked up at a discount from a disappointed AstraZeneca, also comes with a black box warning on suicidal thinking that will almost certainly squeeze its slice of the market down to a sliver.

“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,” said Andrew Greenspan, Vice President of Medical Affairs at Janssen. “Considering this, we applied a priority review voucher to the application for Tremfya to bring this novel treatment to patients sooner.”


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 31,500+ biopharma pros who read Endpoints News by email every day.

Free Subscription


Chief Medical Officer
Skyhawk Therapeutics Waltham, MA
Chief of Staff, North America
Ipsen Biopharmaceuticals Cambridge, MA
Senior Director, NA Digital Customer Interaction
Ipsen Biopharmaceuticals Cambridge, MA
GMP Supervisor - Downstream
Molecular Templates Austin, TX
Quality Control (QC) Associate
Molecular Templates Austin, TX

Visit Endpoints Careers ->