Janssen’s TREMFYA One-Press Patient-controlled Injector for Adults with Plaque Psoriasis Receives FDA Approval

TREMFYA One Press

Janssen Pharmaceutical’s TREMFYA® One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis received FDA approval. TREMFYA is the first FDA-approved medication of its kind to offer the One-Press patient-controlled injector.

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One-Press was designed with patients in mind: it fits comfortably in the hand and offers a controlled injection that hides the needle throughout the process. TREMFYA is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. TREMFYA is intended for use under the guidance and supervision of a physician, and patients may self-inject with TREMFYA One-Press after physician approval and proper training. TREMFYA One-Press is now available in the U.S, said a press release.

Plaque psoriasis is a chronic autoimmune condition. It appears on the skin in patches of thick, red, scaly skin. Plaque psoriasis is the most common form of psoriasis, affecting about 6.7 million adults in the United States. The condition can be very itchy and sometimes painful.

Janssen Tremfya

Many people find it hard to self-administer treatments for plaque psoriasis because of reasons such as needle phobia. Study showed that patients were very satisfied with the One-Press injector. The mean score for “Satisfaction with Self Injection” was 9.18 (with 10 indicating “Very Satisfied”) and the mean score for “Ease of Use” was 9.24 (with 10 indicating “Very Easy”).

To study the efficacy and safety of TREMFYA administered with One-Press, a double-blind, placebo-controlled ORION study was conducted. The results showed TREMFYA was very effective and safe.

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“The results of the ORION study showed the administration of TREMFYA with One-Press was safe and effective, providing patients with a new, more convenient way to inject their treatment,” said Laura Ferris, M.D., Ph.D., Associate Professor, Department of Dermatology, University of Pittsburgh Medical Center. “These findings are also exciting as they demonstrated that treatment with TREMFYA helped half the patients achieve complete clearance with a PASI 100 response at week 16.”