Johnson & Johnson has been boosted by the news that regulators in Europe have given the firm’s Janssen-Cilag unit the green light to market its new biologic Stelara for the treatment of psoriasis.

Stelara (ustekinumab), the first in a new class of biologics which targets the cytokines interleukin-12 and -23, has been approved by the European Commission specifically for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus ultraviolet A light).

The approval is based on data from two Phase III trials (Phoenix 1 and 2) involving nearly 2,000 patients. Results of those studies showed that two-thirds of patients treated with ustekinumab experienced significant skin clearance (75%) by week 12 and sustained efficacy through at least week 76 with Stelara maintenance therapy every 12 weeks.

The European approval is welcome for J&J, seeing as it comes just a month after the US Food and Drug Administration issued the firm’s Centocor unit with a complete response letter. The agency asked for a “risk evaluation and mitigation strategy” to ensure that the benefits of ustekinumab outweigh the risks. The REMS must contain a medication guide and communication plan. However J&J noted that the FDA did not request any additional studies.