Janssen seeks US approval for guselkumab to treat plaque psoriasis

The company submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the investigational anti-interleukin (IL)-23 monoclonal antibody.

Guselkumab targets IL-23, a protein which has been demonstrated to play an important role in the development of immune-mediated inflammatory diseases.

The BLA was based on data from four studies assessing the efficacy and safety of guselkumab administered by subcutaneous injection in the treatment of adults living with moderate to severe plaque psoriasis.

The studies include Voyage 1, Voyage 2 and Navigate phase III trials, and the X-plore phase II study.

Janssen Research & Development immunology development head Newman Yeilding said: “We are committed to translating scientific advances into innovative therapies for chronic immune-mediated diseases like plaque psoriasis.

“We look forward to working with the FDA during the agency’s review of the application as we believe guselkumab addresses continued needs of patients living with moderate to severe plaque psoriasis.”

Guselkumab showed promise in the treatment of active psoriatic arthritis in a phase 2 study.

The study met its primary endpoint, where 58% of patients receiving guselkumab achieved at least a 20% improvement in signs and symptoms of disease (ACR 20) at week 24, compared with 18.4% of those receiving placebo (P < 0.001).

The trial also demonstrated statistically significant enhancements in all secondary endpoints including physical function, psoriatic skin lesions and other health related outcomes, compared with patients receiving placebo.

Image: Plaques of psoriasis. Photo: courtesy of James Heilman, MD.