Janssen gets FDA approval for Tremfya One-Press patient-controlled injector


Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for its Tremfya (guselkumab) One-Press patient-controlled injector for adults with moderate-to-severe plaque psoriasis.

Tremfya is claimed to be the first FDA-approved medication of its kind to provide the One-Press patient-controlled injector.

After starter doses at weeks zero and four, Tremfya is administered as a 100mg subcutaneous injection once every eight weeks.

During the phase 3 multicenter and randomized Orion study, the patient experience with One-Press was evaluated through a validated self-injection assessment questionnaire (SIAQ), which assessed patient experience at weeks zero, four and 12 on a scale of zero (worst) to ten (best) across six domains.

Orian is a phase 3 study designed to assess the pharmacokinetics, efficacy and safety of Tremfya administered with the One-Press injector. The 78 patients have been randomized to receive either Tremfya or placebo.

According to the company, major proportion of patients in the Tremfya group achieved an IGA score of zero or one or a PASI 90 response at week 16 than in the placebo group in the study, said Janssen.

One-Press design enables patients to control the rate and pressure of their injection. A soft click indicates when administration is complete, resulting around 99% of patients reporting a successful first injection.

One-Press is also comprised of a safety system, which protects the needle after use. Patients still reported supportive outcomes with the usability of the One-Press device, after three injections.

Developed by Janssen, Tremfya is a human monoclonal antibody that selectively inhibits the protein interleukin (IL)-23. It is approved in the US, Canada, European Union, Japan and multiple other countries to treat adult patients with moderate-to-severe plaque psoriasis.

Janssen Research & Development immunology development head Dr Newman Yeilding said: “Patients living with plaque psoriasis often struggle with a conventional syringe when administering treatment.

“With the approval of One-Press, patients now have the option to self-administer TREMFYA with a novel device that is both simple and intuitive to use.”