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GSK and J&J move closer to sirukumab filing for arthritis

On course for third quarter application in a bid to catch up with Sanofi’s sarilumab

Positive phase III data on its rheumatoid arthritis candidate sirukumab has placed GlaxoSmithKline and partner Johnson & Johnson on course for filings in the third quarter.

The interleukin-6 (IL-6) inhibitor met all its objectives in the SIRROUND-D study, which involved adult patients with moderately to severely active RA who had not responded adequately to disease-modifying anti-rheumatic drugs (DMARDs).

GSK and J&J's Janssen Biologics unit are aiming to position sirukumab as a best-in-class IL-6 inhibitor with advantages over Roche's $1.5bn Actemra (tocilizumab) product, currently the only approved drug in the class for RA.

The two companies are in a race to market with Sanofi, whose sarilumab has already been filed for approval in the US and has a review date of 30 October.

Results presented at this week's Annual European Congress of Rheumatology (EULAR 2016) in London, UK, showed that sirukumab slowed down the progressive joint destruction in RA and improved the symptoms of the disease.

Patients treated with sirukumab experienced significantly less joint destruction than placebo over a year - as measured by the Sharp van der Heijde Score, a method used to measure joint damage observed in X-ray images.

The sirukumab group was also superior to placebo in the proportion of patients achieving an ACR20 response - a 20% improvement in RA symptoms - after 16 weeks of treatment.

Around 54% of patients on the drug achieved an ACR20, which was a significant improvement over placebo but not as impressive as the 84% improvement seen in phase II testing. The drug performed about as well as sarilumab, which averaged a 56%-60% improvement in phase III testing.

The drug also met all its secondary objectives, including a significant improvement in ACR50 and ACR70 scores.

Sirukumab and sarilumab's developers insist their drugs are not me-too agents as they have different characteristics to Actemra, including greater affinity for IL-6. US and EU guidelines support the use of IL-6 inhibitors earlier in the course of RA treatment, they note, particularly for patients who cannot take methotrexate-based therapies.

They also hope that having multiple IL-6 inhibitors available will help grow the overall market for the class as an alternative to TNF inhibitors, although they have a short window of opportunity as Actemra will start to lose patent protection in 2019.

GSK and J&J also have phase III trials of sirukumab in patients who have not responded to TNF blockers such as AbbVie's Humira (adalimumab), methotrexate and methotrexate plus sulfasalazine.

The partners are also running a head-to-head comparison with Humira in methotrexate non-responders, but are also playing catch-up with Sanofi on this front as sarilumab has already bested AbbVie's drug in a comparative trial.

Article by
Phil Taylor

9th June 2016

From: Research



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