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Janssen’s Tremfya cleared for European use

EC approves the medicine to treat adults with plaque psoriasis

EU

The European Commission (EC) has given the go-ahead to Janssen’s Tremfya (guselkumab), approving the drug to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

The drug is a follow-up for its IL-23/IL-12 inhibitor Stelara, which is facing competition from newer psoriasis drugs showing greater efficacies in clinical trials.

Tremfya, an anti-IL-23 monoclonal antibody, was developed using MorphoSys’ HuCAL antibody library technology, allowing the German biotech to collect royalties on Tremfya sales under a multiple target deal it struck with Janssen back in 2000.

Dr Simon Moroney, chief executive officer, MorphoSys, said: “We are very pleased that Janssen has now received market authorisation for Tremfya in Europe after US approval was granted in July of this year.

“We expect this drug will provide an important treatment option for patients living with moderate-to-severe plaque psoriasis.”

The drug’s approval was based on two-phase III studies, VOYAGE 1 and 2, which compared guselkumab with placebo and AbbVie’s blockbuster Humira (adalimumab).

Patients on Tremfya showed ‘high’ levels of skin clearance after 16 weeks with at least a 90% reduction in psoriasis area and severity index score (PASI 90) in just over 73% and 70% of patients.

However, only 49.7% and 46.8% of patients taking Humira achieved a PASI 90, setting up a potential advantage for Tremfya as it takes on Novartis’ IL-17 inhibitor Cosentyx (secukinumab) in an already-crowded psoriasis market.

Meanwhile beyond the plaque psoriasis indication, Janssen is further studying Tremfya, in a phase III psoriatic arthritis development programme.

Tremfya’s European approval was immediately followed by its launch in the UK, where its appraisal by NICE began at the end of August with guidance expected to be published in June 2018.

Article by
Gemma Jones

24th November 2017

From: Regulatory

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