J&J's block­buster Ste­lara wins US ap­proval for ul­cer­a­tive col­i­tis

J&J’s Ste­lara, which is set to be in the top ten list of block­busters come 2025, is now cleared by the FDA for use in ul­cer­a­tive col­i­tis (UC), an in­flam­ma­to­ry dis­ease of the large in­tes­tine.

The bi­o­log­ic tar­gets in­ter­leukin (IL)-12 and IL-23 cy­tokines, which are known to play a key role in in­flam­ma­to­ry and im­mune re­spons­es. Ste­lara, which gen­er­at­ed about $4.7 bil­lion in the first nine months of 2019, is a key play­er in the crowd­ed mar­ket­place of drugs to treat au­toim­mune dis­or­ders such as pso­ri­a­sis, rheuma­toid arthri­tis and Crohn’s dis­ease. Ab­b­Vie’s star ther­a­py, Hu­mi­ra, con­tin­ues to dom­i­nate, de­spite its loom­ing patent cliff in the Unit­ed States, while oth­ers in­clud­ing J&J’s $JNJ own an­ti-IL23 Trem­fya, Lil­ly’s $LLY an­ti-IL-17 Taltz and Ab­b­Vie’s $AB­BV re­cent­ly ap­proved an­ti-IL-23 an­ti­body Skyrizi carve out a slice of mar­ket share.

The UC ap­proval was based on a 972-pa­tient place­bo-con­trolled piv­otal tri­al in mod­er­ate­ly-to-se­vere­ly ac­tive ul­cer­a­tive col­i­tis pa­tients who did not de­rive ad­e­quate ben­e­fit or were un­able to tol­er­ate con­ven­tion­al or bi­o­log­ic ther­a­pies.

In the in­duc­tion por­tion of the study, pa­tients re­ceived a sin­gle in­tra­venous in­fu­sion of Ste­lara (6 mg/kg) or a place­bo. Da­ta showed 19% of pa­tients re­ceiv­ing Ste­lara achieved clin­i­cal re­mis­sion in just 8 weeks. In ad­di­tion, 58% of pa­tients re­ceiv­ing Ste­lara ex­pe­ri­enced a clin­i­cal re­sponse at week 8.

Pa­tients who ex­pe­ri­enced a clin­i­cal re­sponse were then en­rolled in the main­te­nance tranche of the tri­al, in which they were giv­en sub­cu­ta­neous in­jec­tions of Ste­lara (90 mg) every two months for 44 weeks. Da­ta showed 45% of pa­tients re­ceiv­ing Ste­lara were in re­mis­sion at one year. In ad­di­tion, 43% of Ste­lara-treat­ed pa­tients were in clin­i­cal re­mis­sion and not re­ceiv­ing steroids at the end of the year.

On Mon­day, J&J al­so un­veiled two-year da­ta from the long-term ex­ten­sion to the UNIFI study on 399 par­tic­i­pants who un­der­went both the in­duc­tion and the main­te­nance por­tion of the study.

Da­ta showed that the ma­jor­i­ty of pa­tients were able to sus­tain re­mis­sion at week 92, J&J said.

Ste­lara was first ap­proved in Sep­tem­ber 2009 for plaque pso­ri­a­sis and has since se­cured ap­proval for pso­ri­at­ic arthri­tis, Crohn’s dis­ease, and now ul­cer­a­tive col­i­tis.

Ul­cer­a­tive col­i­tis is one of the two ma­jor types of in­flam­ma­to­ry bow­el dis­ease, along with Crohn dis­ease. UC af­fects ap­prox­i­mate­ly 910,000 adults in the Unit­ed States and men are more like­ly than women to be di­ag­nosed, J&J es­ti­mat­ed.

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