FDA approves Tremfya (guselkumab) to treat plaque psoriasis.- Janssen Biotech.

Janssen Biotech, Inc. announced that the FDA has approved Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Approval comes after an expedited regulatory review following application of an FDA Priority Review Voucher.

Tremfya is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. 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. Superior results in skin clearance (PASI 90) were demonstrated with Tremfya compared with Humira (adalimumab) at weeks 16, 24 and 48.

Comment: Tremfya joins a market of recently approved drugs for psoriasis in the US, which are Cosentyx (secukinumab ) from Novartis, Taltz (ixekizumab) from Eli Lilly and Siliq ( brodalumab) from Valeant Pharma. As a first-in-class agent, Tremfya offers a new alternative to patients. IL-23 works upstream in the inflammatory cascade compared to IL-17 or TNF, which the company believes could offer efficacy advantages.