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.