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J&J uses FDA Priority Review Voucher to snag psoriasis approval

Published on 14/07/17 at 08:21am

The FDA has handed out another approval, as the agency now easily surpasses last year’s figure of 22 already, this time as Janssen was granted approval for its treatment of moderate-to-severe psoriasis.

The company used its Priority Review Voucher to shave off four months from the approval process for the drug, which is thought to hold the potential to become a new blockbuster treatment in the area.

Tremfya (guselkumab) enters the market to join Novartis’ market-leader, Cosentyx, Eli Lilly’s Taltz and Valeant’s Siliq.

Its competitors’ action specifically target the pro-inflammatory cytokine, interleukin 17, and this wave of psoriasis drugs have become dominant wave of treatment in the area. This new batch of treatment have displaced Janssen’s own, older product, Stelera, as a more effective means of improving skin clearance.

Janssen will be hoping that Tremfya can make up for the inevitable loss in sales to Stelera, which raked in over $3 billion in sales last year. The company will be hoping that its product can differentiate itself in the market to hold its own against Novartis’ and Eli Lilly’s products. Valeant’s Siliq will pose less of a challenge, given that it is required to have a black box warning regarding suicidal thinking as a side-effect.

One way in which Tremfya is different to its competitors in the market is that it targets a different cytokine, specifically, interleukin 23. Janssen are hoping that this different method of action can prove that it holds advantages over its competitors by pitting the product against the leader in the new wave, Cosentyx, in clinical trials.

Andrew Blauvelt, President of Oregon Medical Research Center, and study investigator said, “We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease, which is another reason why today’s approval of Tremfya is exciting, both as a researcher and a practicing dermatologist.”

The speedy approval has actually been a long time in the making – Janssen had originally received its priority review voucher back in 2012, through the development of Sirturo. This drug became the first new TB drug to reach the market in more than 40 years and successfully gained the company the valuable voucher as part of the incentive to encourage research into neglected disease areas.

Janssen had licensed the drug from Morphosys and the German biotech stands to gain from moderate royalties after its work developing the antibody, shares in the company rose 11% as a result of the FDA’s approval.

Ben Hargreaves

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