The US Food and Drug Administration (FDA) has granted approval for Janssen Pharmaceutical’s Tremfya (guselkumab) One-Press injector to treat moderate-to-severe plaque psoriasis in adults.

Psoriasis is a skin condition characterised by red lesions of dry skin coated in scales, which typically manifest on the joints, scalp and lower back but can appear anywhere on the body. These are known as plaques

The One-Press injector designed to treat the condition is a single-dose, patient-controlled device. Tremfya is said to be the first of its kind in the US to offer this form of drug delivery for psoriasis treatment.

The design enables patients to control the injection’s rate and pressure, and hides the needle throughout the process.

Tremfya is a monoclonal antibody developed to block the interleukin (IL)-23 protein. This protein is thought to trigger the overproduction of skin cells which leads to psoriasis plaques.

The drug has approval across multiple countries, including Canada and European Union.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
“Patients living with plaque psoriasis often struggle with a conventional syringe when administering treatment.”

It is given as a 100mg subcutaneous injection every eight weeks, after starter doses at weeks 0 and 4.

Patient experience with Tremfya One-Press was evaluated in a multi-centre, randomised, double-blind Phase III ORION clinical trial.

Assessment at weeks 0, 4 and 12 showed that participants found the injector administration satisfactory and easy to use.

Most of the injection-site reaction symptoms with One-Press were observed to be mild and transient.

The trial also assessed the drug’s efficacy and safety. Results showed that greater proportion of patients in the Tremfya arm experienced an Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16, compared to placebo group.

More patients treated with the drug achieved 90% improvement in baseline psoriasis area severity index (PASI) score (PASI 90) at week 16.

Janssen Research & Development Immunology Development head 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.”

In December last year, Janssen reported positive data from the Phase III Eclipse trial that compared Tremfya with Novartis’ Cosentyx (secukinumab) in adults with moderate to severe plaque psoriasis.

Tremfya demonstrated superiority for the primary endpoint with 84.5% patients achieving PASI 90 at week 48.