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October 24, 2019

Janssen applies to EMA for Tremfya approval in psoriatic arthritis

Janssen Pharmaceutical has filed a type II variation application with the European Medicines Agency (EMA) for the approval of Tremfya (guselkumab) to treat active psoriatic arthritis (PsA) in adults.

Janssen Pharmaceutical has filed a type II variation application with the European Medicines Agency (EMA) for the approval of Tremfya (guselkumab) to treat active psoriatic arthritis (PsA) in adults.

Previously, the drug received the EMA approval to treat moderate to severe plaque psoriasis. It also has marketing authorisation for the indication in multiple other markets, including the US.

Guselkumab is a human monoclonal antibody that targets the p19 subunit of interleukin (IL)-23, which is involved in the pathogenesis of immune-mediated inflammatory diseases such as PsA and psoriasis.

PsA is a chronic disease that causes joint inflammation and skin lesions, characterised by stiffness, pain and swelling in and around the joints.

Janssen research & development vice-president and rheumatology disease area leader Alyssa Johnsen said: “This submission to the EMA is an important milestone for people with psoriatic arthritis, who currently have limited treatment options that improve the signs and symptoms of the condition.

“With this filing, we hope to offer clinicians a new and innovative treatment option for people living with psoriatic arthritis.”

The company’s type II variation application supports results from the Phase III DISCOVER-1 and DISCOVER-2 clinical trials, part of the DISCOVER programme.

The randomised, double-blind, multi-centre trials compared the safety and efficacy of subcutaneous Tremfya to that of placebo in 381 and 739 active PsA patients, respectively.

DISCOVER-1, set to continue through around 12 months, includes patients who received prior anti-TNF therapy. DISCOVER-2 enrolled biologic-naïve participants and would take place through nearly 24 months.

During clinical development, guselkumab was found to be generally well-tolerated.

Drug-related adverse events were injection site erythema, diarrhoea, upper respiratory infection and arthralgia, as well as gastroenteritis, tinea infections, headache, urticaria and herpes simplex infections.

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