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.”

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