Stelara, Treatment for Moderate-to-Severe Crohn’s Disease, Approved for Use in EU

Stelara, Treatment for Moderate-to-Severe Crohn’s Disease, Approved for Use in EU
The European Commission (EC) has approved Stelara (ustekinumab) for the treatment of adults with moderate-to-severe Crohn’s disease who had no improvements with other therapies, the drug developer's, Janssen, announced. Stelara is a monoclonal antibody antagonist of human interleukin-12 and interleukin-23, molecules that are believed to play a role in the autoimmunity that leads to disorders such as Crohn’s disease. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe active Crohn’s disease in adults in September. “Today’s decision is an important step forward for people living with Crohn’s disease,” Frederic Lavie,  EMEA Therapeutic Area Leader for Immunology, Cardiovascular and Metabolics at Janssen, said in the press release. “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.” The approval follows the positive opinion issued in September by the Committee for Medicinal Products for Human Use (CHMP), the scientific board of European Medicines Agency (EMA), and was based on results from the Phase 3 UNITI clinical program. This program included three studies: UNITI-1, UNITI-2 and IM-UNITI, involving 1,400 Crohn’s disease patients, and demonstrated the potential of Stelara to provide significant benefit for patients in need of an effective therapy. In UNITI-1 (NCT01369329), Stelara was found to induce clinical response and remission in patients who had previously failed or were intolerant to treatment with one or more TNF blockers. Overall, 34% of patients reported relief
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