FDA approves J&J’s Tremfya self-injection pen for psoriasis

FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis.

The self-injection approval may help Tremfya compete with AbbVie’s  (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients.

Made by J&J subsidiary Janssen Pharmaceuticals (Horsham, Penn.), Tremfya is a biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis, according to Janssen. Tremfya is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4.

FDA cleared J&J’s Tremfya in 2017. In clinical studies, patients receiving Tremfya experienced significant improvement in skin clearance and greater improvement in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness when compared with placebo at week 16, according to Janssen.