Regulatory Focus™ > News Articles > Janssen's Simponi Wins New Indication for Treatment of Ulcerative Colitis

Janssen's Simponi Wins New Indication for Treatment of Ulcerative Colitis

Posted 16 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced the approval of additional indications for Simponi (golimumab), a drug manufactured by Janssen Biotech intended to treat adults with moderate to severe ulcerative colitis (UC).

The drug is one of at least four approved this week by the agency, but unlike two others, Breo Ellipta and Xofigo, the drug is not a new molecular entity, which are particularly heralded by the agency as being proof of it accommodating innovation.

Simponi, a human monoclonal antibody, was first approved in the US in April 2009 for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The drug's then-sponsor, Centocor Ortho Biotech, has since changed its name to Janssen, which is a subsidiary of life sciences manufacturing giant Johnson & Johnson.

New Approval Indication

In its new approval announcement on 15 May 2013, FDA explained that the drug works by blocking tumor necrosis factor (TNF), which is involved in promoting inflammation and immune system responses.

"Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis," explained Andrew Mulberg, deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research (CDER). "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."

FDA said two studies involving 823 combined patients found the drug to do a better job at treating UC than a placebo, with more patients achieving remission at both 30 and 54 weeks after starting treatment. The most common side effects are upper respiratory infection and redness at the site of injection.

In a statement, Janssen called the approval a "notable milestone for adults living with this chronic, devastating disease for which there is no cure."

The drug is specifically indicated for adult patients with moderate to severe UC that is either resistant to prior treatment or requires continuous steroid therapy.

UC affects approximately 620,000 Americans, causing inflammation and ulcers within the lining of the large intestine.

FDA's Approval of Simponi

Janssen Statement on Approval

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