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.

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