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Janssen files Tremfya for psoriatic arthritis in Europe

Hopes to extend use beyond plaque psoriasis

Tremfya

Johnson & Johnson’s Janssen division has filed its immunology therapy Tremfya for psoriatic arthritis (PsA) in Europe, hoping to extend use of the drug beyond plaque psoriasis.

First approved in Europe two years ago, Tremfya (guselkumab) is the follow-up to J&J’s IL-12/IL-23 inhibitor blockbuster Stelara (ustekinumab), which is facing increased competition across many of its approved uses from newer biologic therapies including Novartis’ IL-17 inhibitor Cosentyx (secukinumab).

If approved by the EMA, Tremfya will be the first selective IL-23 inhibitor for people with active PsA in the EU. That could extend the drug’s lead in Europe over its main rival in the class, AbbVie’s Skyrizi (risankizumab), which was approved in Europe for psoriasis earlier this year.

It’s a different picture in the US, where Skyrizi has already been cleared for both psoriasis and PsA, while Tremfya is also approved for psoriasis but was only filed in PsA last month. Some analysts suggest Skyrizi matches Tremfya for efficacy but offers less frequent dosing during the maintenance phase of treatment, as well as competitive pricing.

The new PsA filing is based on the results of two phase 3 trials of Tremfya – DISCOVER-1 and DISCOVER-2 – that met the primary endpoint of a 20% improvement in PsA symptoms (ACR 20 response) at week 24.

The antibody also improved several secondary measures, including ACR 50 and ACR 70 responses and showed signs that it could improve physical function in PsA patients.

Sales of Tremfya reached $742m in the first nine months of 2019 and should easily top the $1bn sales threshold for the full-year, but hasn’t matched the sales trajectory of Stelara – which made $4.66bn in the first three quarters – in its first couple of years on the market.

Stelara is facing the threat of biosimilar competition in the US from 2023, so J&J needs to build as much momentum for Tremfya as it can – including approvals in new indications like PsA, Crohn’s disease, and ulcerative colitis – to compensate.

That could be a challenge, as Skyrizi, Cosentyx and other drugs like Eli Lilly’s IL-17 inhibitor Taltz (ixekizumab) and Pfizer’s oral JAK inhibitor Xeljanz (tofacitinib) are all staking claims to those indications, and biosimilars of first-generation biologics such as the TNF inhibitors are rolling onto the market.

In August, Lilly presented results of a head-to-head trial of Taltz versus Tremfya in psoriasis which suggested its drug was better at achieving complete clearance of skin lesions, although the full data set hasn’t yet been scrutinised by clinicians.

Lilly’s drug also outperformed AbbVie’s $20bn TNF inhibitor blockbuster Humira (adalimumab) in PsA in the SPIRIT trial reported this summer at the EULAR congress.

Article by
Phil Taylor

23rd October 2019

From: Regulatory

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