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J&J's Simponi wins FDA approval in ulcerative colitis

Adds to rheumatoid arthritis, psoriatic arthritis and active ankylosing spondylitis indications in the US

Johnson and Johnson J&J Simponi golimumab

Johnson & Johnson's (J&J) Simponi will now be available to even more patients in the US after it received FDA approval as a treatment of moderate to severe ulcerative colitis.

The drug is already approved in the US to treat rheumatoid arthritis, psoriatic arthritis and active ankylosing spondylitis, with sales topping $607m during 2012.

Ulcerative colitis - an inflammation of the large intestine - is thought to affect about 620,000 Americans, and this extra market is expected to further boost sales of Simponi (golimumab), with Bloomberg reporting analysts' estimates that it could achieve annual sales of $1.2bn by 2016.

Not everyone in the US with the condition will have access to Simponi, however, as the approval will only cover adults with moderate to severe ulcerative colitis that is resistant to prior treatment or requires continuous steroid therapy.

J&J is also a step behind AbbVie, which gained approval last year for its huge selling immunotherapy Humira to treat ulcerative colitis.

Nevertheless, the approval is good news for J&J, which intends to market the drug through its subsidiary Janssen Biotech.

“The approval of Simponi for the treatment of ulcetarive colitis is a notable milestone for adults living with this chronic, devastating disease for which there is no cure,” said Dr Cindy Guzzo, VP, medical affairs, Janssen Biotech.

“As leaders in the treatment of IBD for more than a decade, we are proud to offer a new subcutaneous treatment option to patients and healthcare providers where unmet need continues to exist.”

The FDA also emphasised the need for further treatment options for a condition that can lead to abdominal discomfort, gastrointestinal bleeding, production of pus and diarrhoea.

The agency's deputy director of the Division of Gastroenterology and Inborn Errors Products Dr Andrew Mulberg said: “It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently.”

Simponi is currently under review for the condition in the EU, where it is also approved to treat rheumatoid arthritis, psoriatic arthritis and active ankylosing spondylitis.

17th May 2013

From: Sales



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