J&J's Stelara clinches ulcerative colitis nod to back up declining Remicade

Stelara racked up $1.7 billion in worldwide sales in Q3. (Johnson & Johnson)

Under assault from newer therapies in the anti-inflammatory market, Johnson & Johnson has focused on expanding Stelara beyond dermatology—and Monday, it took another big step in that direction.

The FDA approved Stelara to treat adults with ulcerative colitis (UC), a condition that affects around 910,000 U.S. patients each year. Regulators based the decision on two phase 3 clinical trials: In one, 19% of patients on Stelara achieved remission at eight weeks while another showed 45% of Stelara patients hit remission by the one-year mark.

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The latest nod—Stelara’s second in the gastrointestinal field, after Crohn’s—will help the drug build on the $1.7 billion in worldwide sales it posted in the third quarter, a nearly 30% jump from the same quarter in 2018.

It will also give the drug a sales avenue where its newer psoriasis competitors—including Novartis blockbuster Cosentyx, which topped Stelera in a head-to-head study on the way to approval—don’t currently compete.

That’s not to say Stelara won’t face rivals in ulcerative colitis. But one major player, Pfizer’s Xeljanz, was recently hobbled in that department by an FDA black box warning and a decree from the agency the drug should be used only among those who don’t respond to or aren’t suited for other meds.

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J&J is looking to Stelara, along with new immunology drug Tremfya, to help it overcome the continued downfall of longtime immunology blockbuster Remicade as biosimilar challengers strip away its market value.

Remicade, once the franchise’s crowning achievement, dropped a precipitous 17.6% in the third quarter to $1.1 billion in sales.

Stelara’s strong growth over the same period, though, puts it well on its way to GlobalData’s lofty forecast of $7.5 billion in worldwide sales in 2025—a figure that would rank it ninth among the industry’s top global sellers.