FDA Expands Approval for J&J’s Psoriasis Biologic

Janssen Biotech, a Johnson & Johnson company, received approval on Oct. 13, 2017 from FDA for an expanded indication for its psoriasis biologic, Stelara (ustekinumab), to treat adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Stelara is one of the company’s top-selling products with 2016 sales of $3.2 billion.

Stelara, a fully human interleukin (IL)-12 and IL-23 antagonist, was first approved by FDA in September 2009 for treating moderate to severe plaque psoriasis in adults. It is also indicated for treating adult patients 18 years and older with active psoriatic arthritis, alone or with methotrexate, and for treating moderately to severely active Crohn’s disease in adult patients 18 years or older who have already taken other medicines that did not work well enough or were not well tolerated.