Pharma Tips

FDA approves Simponi to treat ulcerative colitis

By: Pharma News | Views: 865 | Date: 23-Jul-2013

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to

FDA approves Simponi to treat ulcerative colitis

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.


Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.

Ulcerative colitis is a chronic disease that affects about 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, production of pus and diarrhea.

“Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis,” said Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “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.”

The safety and effectiveness of Simponi for ulcerative colitis were established in two clinical studies. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician’s overall assessment.

In the first study, 513 patients with moderate to severe ulcerative colitis who could not tolerate or failed to respond to other therapies were randomly assigned to receive Simponi or a placebo. Results showed that a greater proportion of Simponi-treated patients achieved clinical response, clinical remission and, as seen during endoscopy, had improved appearance of the colon after six weeks compared with the placebo group.

In the second study, 310 patients with moderate to severe ulcerative colitis who were responders to Simponi were randomly assigned to receive Simponi or placebo. A greater proportion of Simponi-treated patients maintained clinical response through week 54 and had clinical remission at both weeks 30 and 54.

The most common side effects in patients treated with Simponi are upper respiratory infection and redness at the site of injection. Patients treated with Simponi are at increased risk of developing serious infections, invasive fungal infections, and reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders and allergic reactions.

Simponi is marketed by Horsham, Penn.-based Janssen Biotech, Inc.

Previous Page Next Page

People Searching On This Page:
  • olitis pharma company director
  • simponi ulcerative colitis effectiveness
  • simponi
  • quality management

Related Pages


FDA 'No' for Gilead HIV Drugs Elvitegravir and Cobicistat

FDA 'No' for Gilead HIV Drugs Elvitegravir and Cobicistat

News | FDA
Date:
03-May-2013  Views: 1346

Gilead Sciences has suffered a setback after regulators in the USA rejected two of the components of its four-in-one HIV drug Stribild as stand-alone ...
FDA approves Raptor's orphan disease drug Procysbi

FDA approves Raptor's orphan disease drug Procysbi

News | FDA
Date:
03-May-2013  Views: 1107

The US Food and Drug Administration have approved Raptor Pharmaceuticals' Procysbi for the management of a rare genetic disease called nephropathic cy ...
FDA Budget Requests $4.7 Billion

FDA Budget Requests $4.7 Billion

News | FDA
Date:
18-Apr-2013  Views: 983

The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fisca ...
Production Executive in FDA Approved Pharma Company

Production Executive in FDA Approved Pharma Company

Jobs | Production | Baddi
Date:
20-Feb-2013  Views: 2230

Posted By - leading pharmaceutical company. Keywords - production executive, FDA Aprroval, B.Pharm, granulation section. Job Description - Candidate h ...
FDA Approves First Cell Culture Flu Vaccine

FDA Approves First Cell Culture Flu Vaccine

Articles | Pharmaceutical Drugs
Date:
04-Dec-2012  Views: 1387

The first seasonal influenza vaccine licensed in the United States produced using cultured animal cells instead of fertilized chicken eggs has been ap ...
Post Your Comments (No Login Require)
Name : (required)
Email : (required)
Website :

Comment : (required)

69  + 1 =     
Comments
People Searched About:
Olitis Pharma Company Director   |   Simponi Ulcerative Colitis Effectiveness   |   Simponi   |   Quality Management   |  
Google : 108 times | Yahoo : 20 times | Bing : 13 times |