Janssen Announces U.S. FDA Approval of Novel TREMFYA® (guselkumab) One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis

February 28, 2019/BioValleyBIOON/--Janssen Pharmaceuticals, a subsidiary of the US pharmaceutical giant Johnson & Johnson (JNJ), recently announced that the US Food and Drug Administration (FDA) has approved Tremfya® One Press, a single-dose, patient-controlled syringe for the treatment of adult patients with moderate to severe plaque psoriasis.

Tremfya (guselkumab) isFDAThe first approved product featuring the One-Press patient-controlled injector. One-Press is meticulously designed for patients: it fits comfortably in the hand, delivers controlled injections, and keeps the needle hidden throughout the entire process.

Tremfya was approved in July 2017FDAApproved as the first biologic therapy with selective blocking action specifically targeting interleukin-23 (IL-23), a cytokine that plays a key role in plaque psoriasis. Tremfya is a monoclonal antibody administered via subcutaneous injection at a dose of 100 mg, with a dosing regimen of one administration at weeks 0 and 4, followed by one administration every 8 weeks thereafter.

Tremfya must be used under the guidance and supervision of a physician. Upon physician approval and after receiving appropriate training, patients may self-administer Tremfya One-Press. Tremfya One-Press is now available in the United States.

Sometimes, patients with plaque psoriasis may find it difficult to self-administer treatment due to certain factors, including needle phobia. In the multicenter, randomized Phase III ORION study, patient experience with One-Press was assessed using a validated Self-Injection Assessment Questionnaire (SIAQ). Patient experiences across six domains—injection experience, self-image, confidence, pain and skin reactions during or after injection, ease of use of the self-injection device, and satisfaction with self-injection—were evaluated and scored at Week 0, Week 4, and Week 12 (score range: 0 [worst] to 10 [best]). The results showed that the mean score for “satisfaction with self-injection” was 9.18 (with 10 indicating “very satisfied”), while the mean score for “ease of use” was 9.24 (with 10 indicating “very easy”).

The ORION study also evaluated the efficacy and safety of Tremfya administered via the One-Press device in patients with moderate-to-severe plaque psoriasis. In this study, at Week 16, the proportions of patients in the Tremfya group achieving an Investigator’s Global Assessment (IGA) score of 0 or 1 or a PASI 90 response (81% and 76%, respectively) were higher than those in the placebo group (0% for both endpoints). Compared with the placebo group, a higher proportion of patients in the Tremfya group achieved an IGA score of 0 at Week 16 (56% vs. 0%). Furthermore, compared with the placebo group, a higher proportion of patients in the Tremfya group achieved a PASI 100 response at Week 16 (50% vs. 0%). Most injection-site reactions associated with the use of the One-Press device were mild and transient.

Laura Ferris, Associate Professor in the Department of Dermatology at the University of Pittsburgh Medical Center, stated, “The results of the ORION study demonstrate that Tremfya administered via the One-Press delivery system is safe and effective, offering patients a new and more convenient injection therapy. These findings are also exciting because they show that treatment with Tremfya can help up to half of patients achieve PASI 100 response, indicating completely clear skin, by Week 16.”

Janssen Research & Development, LLCImmunologyNewman Yeilding, Head of Development, stated, “Patients with plaque psoriasis are typically treated using traditional syringes. With the approval of One-Press, patients now have the option to self-inject Tremfya using a new device that is both simple and intuitive.”

The One-Press design allows patients to control the speed and pressure of injection, with a gentle click sound indicating completion. Nearly 99% of patients reported successful first-time injections. Additionally, One-Press includes a safety system that protects the needle after use. After three injections, patients still reported favorable outcomes regarding the usability of the One-Press device.

Original Source:Janssen Announces U.S. FDA Approval of Novel TREMFYA® (guselkumab) One-Press Patient-controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis