Janssen-Cilag International NV's STELARA has been approved by the European Commission to treat adult patients who have moderate-to-severe Crohn’s disease and did not respond well to or are immune to conventional therapy or a tumor necrosis factor alpha (TNFa) antagonist.
“Today’s decision is an important step forward for people living with Crohn’s disease,” Janssen's Frederic Lavei said. “There is a great need for alternative effective therapeutic options to help people control their symptoms, and STELARA offers a strong clinical dataset demonstrating high rates of clinical response and remission for those whom biologic therapy is appropriate.”
STELARA is the first biologic therapy designed to treat Crohn’s disease that actively targets the interleukin (IL)-12 and IL-23 cytokines.
“We are proud to be bringing a new class of treatment for Crohn’s disease to this underserved patient population,” Janssen Company Group Chairman Jane Griffiths said. “STELARA has already helped many people living with psoriasis and psoriatic arthritis, and we are committed to working with health authorities across Europe to make it available as quickly as possible for those living with Crohn’s disease.”