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February 28, 2019updated 20 Mar 2019 4:04pm

FDA approves Tremfya injector for plaque psoriasis

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

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.

“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.

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