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Sobi receives expanded EU approval for Kineret

Published on 11/04/18 at 10:20am

Joining its current indication as a treatment for rheumatoid arthritis and cryopyrin-associated periodic syndromes, Sobi’s Kineret has been given approval by the European Commission to include an indication for Systemic Juvenile Idiopathic Arthritis and Adult-Onset Still’s Disease.

Both conditions are a form of Still’s disease, but differ by the age of onset; Still’s disease is a rare form of severe arthritis that affects multiple organs and is associated with fever, rashes and joint inflammation.

Kineret is an interleukin-1 receptor antagonist that will be able to be used in the condition as a monotherapy in those patients with moderate to high disease activity, or in patients who have displayed continued disease activity after treatments with NSAIDS or glucocorticoids.

“We are very pleased with the approval of Kineret in Still’s disease in EU. This allows us to address an important unmet medical need in this patient population. It includes an option for first line treatment as an alternative to steroid treatment”, says Milan Zdravkovic, Chief Medical Officer and Head of Research and Development at Sobi.

In addition to its use as an anti-inflammatory, the results of a study were also released last month looking at the use of the treatment to treat hypogonadism – a reduction or absence in the function of the testicles in men.

The first-of-its-kind study, looking at an anti-inflammatory to boost testosterone production, was able to show that the treatment was able to boost levels by 11% in patients taking Kineret, compared to no significant change in the placebo group.

The research came on the back of the link between high levels of inflammation being associated with lowered levels of testosterone. Further research could open up the possibility for the treatment to be used as an analogue to testosterone replacement therapy.

Kineret achieved sales of $137.45 million dollars during 2017 but with an expanded approval, this should see growth improve further than 14% it achieved on 2016 results.

Ben Hargreaves

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