July 14, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Horsham, Penn. – The U.S. Food and Drug Administration (FDA) approved Janssen Biotech ’s Tremfya (guselkumab) for adults with moderate-to -severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Janssen is a Johnson & Johnson company.
Tremfya was approved based on three clinical trials that included more than 2,000 patients. They were Phase III VOYAGE 1, VOYAGE 2, and NAVIGATE trials.
“Tremfya represents a significant milestone in the treatment of moderate-to-severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23-specific therapy at week 16 and up to week 48,” said Andrew Blauvelt, president of Oregon Medical Research Center, and study investigator, in a statement. “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.”
Tremfya is a human monoclonal antibody. It functions by selectively blocking interleukin (IL)-23. It is administered as a 100mg subcutaneous injection, first at two starter doses at weeks zero and four, then every eight weeks afterwards.
Janssen is also conducting an ongoing Phase III trial of Tremfya for active psoriatic arthritis, and a Phase III trial comparing Tremfya with Novartis ’ Cosentyx (secukinumab) for moderate-to-severe plaque psoriasis.
Tremfya received a quick approval. John Carroll, writing for Endpoints News, says, “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 to slash four months off the FDA’s review process.”
EvaluatePharma projects peak sales for the drug at about $1.6 billion. J&J licensed MorphoSys’ HuCAL antibody library technology, which generated the guselkumab antibody. As a result, Morphosys will receive a milestone payment a well as royalties on Tremfya. Details of the royalties and milestones remain undisclosed.
The results of the Phase III trials were dramatic, although J&J is a little slow in entering the anti-inflammatory arena. But Tremfya may become a dominant drug in the market, including showing up AbbVie ’s Humira in one of the trials, hitting an IGA 0/1 score of 84 percent compared to Humira’s 67.7 percent, and a PASI 90 of 70 percent, compared to Humira’s 46.8 percent.
Carroll writes, “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 percent—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.”
Janssen indicates it will work closely with insurers, providers and pharmacy benefit managers to make Tremfya accessible and affordable. In addition to several patient support programs, it has a co-pay card for patients with commercial insurance that cuts out-of-pocket costs to no more than $5 per dose.
“The approval of new and effective treatment options is always welcome news for the plaque psoriasis patient community, as not all patients respond similarly to currently available treatments,” said Michael Siegel, vice president of Research Programs for the National Psoriasis Foundation, in a statement. “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.”
