Regulatory Affairs

J&J’s Janssen Biotech gets FDA nod for Tremfya to treat plaque psoriasis

PBR Staff Writer Published 14 July 2017

Johnson & Johnson (J&J) subsidiary Janssen Biotech has secured approval from the US Food and Drug Administration (FDA) for its Tremfya (guselkumab) to treat adults with moderate to severe plaque psoriasis.

The company has received approval for Tremfya to treat adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Tremfya is a human monoclonal antibody that selectively blocks the protein interleukin (IL)-23, which plays a crucial role in plaque psoriasis.

It will be administered as a 100mg subcutaneous injection every eight weeks following two starter doses at weeks zero and 4.

The approval was based on results from a clinical development program, which comprised of more than 2,000 patients in the Phase 3 Voyage 1, Voyage 2 and Navigate studies.

A Phase 3 study assessing Tremfya to treat active psoriatic arthritis is ongoing, while Phase 3 program assessing the efficacy of Tremfya compared with Cosentyx (secukinumab) to treat moderate to severe plaque psoriasis is underway.

The study investigator Dr Andrew Blauvelt said: “Tremfya represents a significant milestone in the treatment of moderate to severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23–specific therapy at week 16 and up to week 48.

“We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease, which is another reason why today’s approval of Tremfya is exciting, both as a researcher and a practicing dermatologist.”

Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.