FDA approves biologic Tremfya for psoriasis

The U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) as an injection to treat moderate to severe plaque psoriasis in adults. Tremfya is the first approved biologic therapy that targets interleukin-23 – a cytokine, or pro-inflammatory protein, that plays a key role in plaque psoriasis.

Tremfya is a biologic (a drug made in a lab from living cells) that prevents your immune system from going into overdrive and creating an undesired immune response resulting in inflammation. The drug has been proven effective in reducing the symptoms of moderate to severe plaque psoriasis – including itch, pain, stinging, burning and skin tightness – in adults who are candidates for systemic therapy (injections or pills) or phototherapy (treatment using ultraviolet or UV light). 

“The approval of new and effective treatment options is always welcome news for plaque psoriasis patients, as not all patients respond similarly to currently available treatments,” said Michael Siegel, Ph.D., Vice President of Research Programs for the National Psoriasis Foundation. “For the more than one million Americans living with moderate to severe plaque psoriasis, the approval of Tremfya offers physicians and patients an effective new therapy.”

Tremfya received FDA approval based on results from a Phase 3 clinical development program that included more than 2,000 patients. In clinical studies, at 16 weeks, at least seven out of 10 Tremfya-treated patients achieved at least 90 percent clearer skin and more than 80 percent demonstrated cleared or almost cleared skin. 

Nearly nine out of 10 Tremfya-treated patients who achieved a score of 90 on the Psoriasis Area and Severity Index (PASI) at week 28 maintained that response at week 48.  

The data from the clinical development program were presented at the 25th European Academy of Dermatology and Venerology Congress in Vienna, Austria, in October 2016 and the 2017 American Academy of Dermatology Annual Meeting in Orlando, Florida, in March 2017.

Tremfya is manufactured by Janssen Biotech.

 


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