The Janssen Pharma, a part of Johnson & Johnson, won FDA approval for its TREMFYA One-Press single-dose injector. The device is used to deliver TREMFYA (guselkumab) as a treatment for moderate to severe plaque psoriasis.
The TREMFYA One-Press allows patients to decide how fast and with how much pressure to deliver the medication. This lets everyone decide how much discomfort they will put up with, while everyone gets the required 100 mg during every injection.
The needle is completely hidden and only comes out when the device is placed against the skin and activated. Physicians are expected to teach patients how to use the TREMFYA One-Press, and once everyone is satisfied, patients can do the injections themselves, something that’s required to be performed once every two months.
TREMFYA One-Press is now available in the U.S.
Here are some details about the facts that led to the approval, according to Janssen:
The efficacy and safety of TREMFYA administered with One-Press in patients with moderate-to-severe plaque psoriasis was also evaluated in the double-blind, placebo-controlled ORION study. In the study, a greater proportion of patients in the TREMFYA group achieved an IGA score of 0 or 1 or a PASI 90 response at week 16 (81 percent and 76 percent, respectively) than in the placebo group (0 percent for both endpoints). The proportion of patients who achieved an IGA score of 0 at week 16 was higher in the TREMFYA group compared to the placebo group (56 percent vs. 0 percent). The proportion of patients who achieved a PASI 100 response at week 16 was higher in the TREMFYA group compared to the placebo group (50 percent vs. 0 percent). The majority of injection-site reaction symptoms with One-Press were mild and transient in nature.
Product page: TREMFYA…