Johnson & Johnson already has a major presence in the crowded inflammatory bowel disease (IBD) space with its popular Stelara. But with biosimilar versions of the autoimmune blockbuster quickly approaching and the Inflation Reduction Act’s price concessions following close behind, a new FDA indication for J&J’s Tremfya could provide a welcome boost for the company.

Wednesday, J&J said the FDA has granted approval for Tremfya in moderate to severely active ulcerative colitis (UC), a form of IBD that impacts more than 1.2 million Americans. The expanded label unlocks a major market for the biologic, which first launched in 2017 to treat plaque psoriasis and added a second approval in psoriatic arthritis three years later.

Tremfya enters crowded ulcerative colitis arena with FDA nod (fiercepharma.com)