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Janssen files Stelara follow-up guselkumab in Europe

Trial data shows J&J’s drug is more effective in treating psoriasis than AbbVie’s Humira
Janssen

Janssen has filed its interleukin-23 inhibitor guselkumab in the EU as a treatment for psoriasis, just a few days after submitting the drug in the US.

Johnson & Johnson's pharma division is positioning guselkumab as a follow-up to its IL-23/IL-12 inhibitor Stelara (ustekinumab), which brought in $2.35bn in the first nine months of the year, and TNF inhibitor Remicade (infliximab) which is also used for psoriasis among other inflammatory diseases but is facing biosimilar competition.

That represented a healthy 36% rise, but Stelara is starting to face stiffer competition from newer psoriasis drugs – including IL-17 inhibitors from Novartis and Eli Lilly which have shown robust efficacy in clinical trials.

Janssen has just presented data showing that guselkumab is more effective in treating psoriasis than AbbVie's top-selling TNF inhibitor Humira (adalimumab), and according to J&J's head of pharma Joaquin Duato is a potential $1bn product that will "provide a significant boost to our leadership in psoriasis".

Patients treated with guselkumab in the VOYAGE 1 study achieved a significantly greater chance of attaining a PASI 90 score (90% improvement in symptoms) compared to patients treated with Humira or placebo after 16 weeks of treatment, and the advantage over adalimumab was sustained through week 48.

The company says guselkumab combines good efficacy with "Stelara-like safety" and a less intensive dosing regimen that will stand it in good stead if approved. Analysts differ on the drug's potential, with some predicting blockbuster sales while others – including Credit Suisse – suggest it will be bringing in around $250m in 2020.

With the filings in the US and EU J&J keeps ahead of its rivals in the IL-23 inhibitor race, including Allergan which has just licensed rights to AstraZeneca's (AZ) MEDI2070 candidate, tildrakizumab from Sun Pharma (formerly MSD) and Boehringer Ingelheim/AbbVie's BI 655066, all of which are still in clinical trials.

It is estimated that 14 million Europeans have psoriasis, which can range from mild to severe and disabling, and can often significantly impair quality of life. 

Article by
Phil Taylor

28th November 2016

From: Regulatory

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