J&J gets FDA okay for psoriasis drug icotrokinra

Johnson & Johnson's much-anticipated oral IL-23 inhibitor, icotrokinra, has claimed FDA approval as a first-line treatment for plaque psoriasis.

The US regulator has approved icotrokinra under the Icotyde brand name for moderate-to-severe plaque psoriasis, making it the first oral IL-23-targeting drug to reach the market. It can be used for patients aged 12 and over who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.

J&J has predicted blockbuster potential for the drug, which combines a tried-and-tested biological mechanism already being deployed in injectable psoriasis therapies, such as J&J's own Tremfya (guselkumab), AbbVie's Skyrizi (risankizumab), and Sun Pharma's Ilumya (tildrakizumab), with the convenience of taking a once-daily pill.

"The approval of Icotyde represents a pivotal moment for people with plaque psoriasis," said J&J's head of innovative medicines R&D, John Reed, describing it as "a fundamentally different [medicine] with the potential to redefine what physicians and patients can expect from psoriasis treatment."

Icotrokinra was highlighted in this year's Drugs to Watch listing by analysts at Clarivate, who have pointed to J&J's confidence in the drug, comparing it in head-to-head trials to Bristol Myers Squibb's oral therapy Sotyktu (deucravacitinib), a TYK2 inhibitor that is the most efficacious oral agent for psoriasis so far, as well as J&J's injectable therapy, IL-12 and IL-23 inhibitor Stelara (ustekinumab), now facing biosimilar competition.

Assuming the Sotyktu studies deliver positive results, the report predicted sales in G7 markets alone (Canada, France, Germany, Italy, Japan, the UK, and the US) will reach $1.5 billion in 2031.

J&J's Stelara – which has a long list of approved indications, including psoriasis – saw sales fall 41% last year to just over $6 billion. Meanwhile, Sotyktu hasn't yet lived up to BMS' ambitious sales projections, bringing in $291 million last year, with its slower-than-expected take-up attributed to payer access challenges, reimbursement hurdles, and reportedly tolerability concerns among prescribers. An approval in psoriatic arthritis could add to its growth momentum this year.

Psoriasis is just the first indication being pursued by J&J in its quest to place Icotyde at the heart of its immunology and inflammation business, with phase 3 studies already underway in psoriatic arthritis and ulcerative colitis, along with a mid-stage trial in Crohn's disease. Analysts at Jefferies have previously suggested global sales could reach a peak of nearly $10 billion.

J&J licensed icotrokinra from Protagonist Therapeutics in 2017 in a deal worth up to $1 billion, including an upfront payment of $50 million. Protagonist has earned a $50 million milestone payment for the US approval and will get royalties on sales of 6% to 10%.

So far, the company has not revealed its planned launch date or list price for Icotyde.