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Amjevita OK'd to Treat Inflammatory Diseases

Posted 27 Sep 2016 by Drugs.com

MONDAY, Sept. 26, 2016 – Amjevita (adalimumab-atto) – a biosimilar drug similar to the popular anti-inflammatory drug Humira – has been approved by the U.S. Food and Drug Administration. Amjevita has been approved for moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis (an arthritis that affects the spine); Crohn's disease; ulcerative colitis; plaque psoriasis and juvenile idiopathic arthritis, the FDA said in a news release. Biological drugs are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast, the FDA said. A biosimilar drug is a biological product that's sanctioned after its maker proves it is "highly similar" to an already-approved biologic drug. The manufacturer of the biosimilar drug must prove that the product has "no clinically meaningful differences" in safety, purity ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Plaque Psoriasis, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Adalimumab, Amjevita

FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Posted 26 Sep 2016 by Drugs.com

September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis. Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. “This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new fr ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Maintenance, Adalimumab, Amjevita

Vitamin A Compound Might Aid in Colon Cancer Fight

Posted 30 Aug 2016 by Drugs.com

TUESDAY, Aug. 30, 2016 – Retinoic acid, a compound derived in the body from vitamin A, might have a role in suppressing colon cancer, new animal research suggests. "Retinoic acid has been known for years to be involved in suppressing inflammation in the intestine," said study senior author Dr. Edgar Engleman, professor of pathology and medicine at Stanford University School of Medicine in Palo Alto, Calif. Meanwhile, the development of colon cancer has been linked to inflammation. For example, inflammatory bowel disease, such as ulcerative colitis, has been associated with colon cancer, he said in a university news release. "We wanted to connect the dots and learn whether and how retinoic acid levels directly affect cancer development," Engleman added. When the researchers looked at mice with colon cancer, they saw lower levels of retinoic acid in the intestines of the mice. The ... Read more

Related support groups: Cancer, Ulcerative Colitis, Colorectal Cancer, Ulcerative Colitis - Active, A-25, Ulcerative Colitis - Maintenance, Vitamin A, Diagnosis and Investigation, Familial Adenomatous Polyposis, A/Fish Oil, Retinol, Aquasol A, Vitamin A Topical

Stool Transplant Soothes Tough-to-Treat Colitis in Study

Posted 23 May 2016 by Drugs.com

MONDAY, May 23, 2016 – Stool transplants helped ease debilitating symptoms and heal the colons of tough-to-treat ulcerative colitis patients, new research shows. Australian scientists said the findings could pave the way for such transplants to be used on a more widespread basis. Transferring fecal matter from healthy donors into these patients alters the composition of their gut bacteria, circumventing one of the drivers of ulcerative colitis, experts said. "We were not completely surprised by the study findings, as . . . smaller studies along with unpublished experience suggested repeated fecal microbiota transplantation may be an effective treatment for ulcerative colitis," said study author Dr. Sudarshan Paramsothy, a gastroenterologist at University of New South Wales. "This study shows that [stool transplant] is a very promising therapeutic option for ulcerative colitis ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Ulcerative Colitis - Maintenance, Diagnosis and Investigation, Fecal Incontinence

Inflectra Approved as 'Biosimilar' to Remicade

Posted 7 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – The U.S. Food and Drug Administration has approved its second-ever "biosimilar" drug, Inflectra, for adults with Crohn's disease, rheumatoid arthritis or chronic plaque psoriasis, among other prescribed uses. In a media release, the agency said Inflectra was biosimilar to Janssen Biotech's Remicade (infliximab), first licensed in 1998. A biosimilar drug is sanctioned based on its maker's ability to show that it is "highly similar" to an already-approved biological drug that is generally derived from a living organism, such as a person, animal, microorganism or yeast, the FDA said. The maker of a biosimilar drug also must prove that the product has no "clinically meaningful difference" in safety and effectiveness from the original drug, and that the newer product has only "minor differences in clinically inactive components" from the original. Inflectra's most ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Remicade, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Plaque Psoriasis, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Inflectra

Ultrasound Might Speed Up Digestive Drug Delivery: Animal Study

Posted 21 Oct 2015 by Drugs.com

WEDNESDAY, Oct. 21, 2015 – Ultrasound waves could be used to rapidly deliver drugs to the digestive system, new animal research suggests. This new approach to drug delivery might potentially benefit people with inflammatory bowel disease (IBD), such as Crohn's disease and ulcerative colitis. However, this new method of drug delivery hasn't yet been tested in humans. "With additional research, our technology could prove invaluable in both clinical and research settings, enabling improved therapies and expansion of research techniques applied to the [gastrointestinal] tract," said co-senior study author Daniel Blankschtein, a professor of chemical engineering at Massachusetts Institute of Technology (MIT) in Cambridge. "[Our study] demonstrates for the first time the active administration of drugs, including biologics, through the GI tract," he said in an MIT news release. The ... Read more

Related support groups: Crohn's Disease, Colitis, Ulcerative Colitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Inflammatory Bowel Disease, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Diagnosis and Investigation

Childhood Abuse Linked to Ulcerative Colitis Later in Life

Posted 11 Sep 2015 by Drugs.com

FRIDAY, Sept. 11, 2015 – Adults who were physically or sexually abused as children may be at increased risk for the inflammatory bowel disease ulcerative colitis, a new study finds. University of Toronto researchers analyzed data from nearly 22,000 Canadians aged 18 and older. They found that those with a history of childhood abuse were nearly twice as likely to have ulcerative colitis as those who hadn't suffered abuse. In ulcerative colitis, inflammation and sores develop in the innermost lining of the large intestine, according to the Crohn's & Colitis Foundation of America. Symptoms include diarrhea, bloody stools and abdominal pain. "We found that one-quarter of adults with ulcerative colitis reported they had been physically abused during their childhood, compared to one in 10 of those without inflammatory bowel disease," study lead author Esme Fuller-Thomson, a professor in the ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Ulcerative Colitis - Maintenance

Crohn's Disease, Colitis Tied to Anxiety in Study

Posted 4 Aug 2015 by Drugs.com

TUESDAY, Aug. 4, 2015 – People with inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, have an increased risk for an anxiety disorder, especially women, a new study suggests. Inflammatory bowel disease (IBD) is a group of disorders that cause chronic inflammation of the digestive tract. "Patients with IBD face substantial chronic physical problems associated with the disease," lead author Esme Fuller-Thomson, a professor from the University of Toronto, said in a university news release. "The additional burden of anxiety disorders makes life much more challenging so this 'double jeopardy' must be addressed." The study authors looked at 269 Canadian adults who had been diagnosed with an inflammatory bowel disease. The researchers found that these patients were two times more likely to have had generalized anxiety disorder at some point in their lives than adults ... Read more

Related support groups: Anxiety, Generalized Anxiety Disorder, Panic Disorder, Anxiety and Stress, Post Traumatic Stress Disorder, Social Anxiety Disorder, Crohn's Disease, Colitis, Ulcerative Colitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Crohn's Disease - Acute, Performance Anxiety, Ulcerative Colitis - Maintenance, Lymphocytic Colitis, Allergic Colitis

Surgery May Beat Drugs for Ulcerative Colitis: Study

Posted 13 Jul 2015 by Drugs.com

MONDAY, July 13, 2015 – Surgery may extend the lives of older adults with the inflammatory bowel disease ulcerative colitis, new research suggests. A study of thousands of adults with the condition compared results of surgery to those of long-term drug treatment. It found that surgery's survival benefit was greatest for those 50 and older who had advanced disease. "Surgery has always been an option," said study leader Dr. Meenakshi Bewtra, but many experts look at it as a last resort. Bewtra, assistant professor of medicine and epidemiology at the University of Pennsylvania Perelman School of Medicine, used data from Medicare and Medicaid for the study. She and her colleagues followed 830 patients who had elective surgery – known as colectomy – and more than 7,500 who took medicine to manage the condition. Surgery involves removal of the colon, sometimes followed by additional ... Read more

Related support groups: Surgery, Ulcerative Colitis, Ulcerative Colitis - Active, Ulcerative Colitis - Maintenance, Gastrointestinal Surgery

FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis

Posted 10 Oct 2014 by Drugs.com

RALEIGH, N.C., October 8, 2014 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon. On September 15, 2014 the FDA tentatively approved Uceris rectal foam pending expiration of the 45-day waiting period described in section 505( c )(3)( C ) of the Federal Food, Drug and Cosmetic Act. The waiting period has expired and the FDA has granted Uceris rectal foam final approval as of October 7, 2014. About ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Budesonide, Ulcerative Colitis - Maintenance, Uceris

Entyvio Approved for Ulcerative Colitis and Crohn's Disease

Posted 20 May 2014 by Drugs.com

TUESDAY, May 20, 2014 – Entyvio (vedolizumab) has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe forms of two gastrointestinal conditions – ulcerative colitis and Crohn's disease. The approval applies to people for whom standard therapies – such as corticosteroids or tumor necrosis factor-blocking medications – have failed. Ulcerative colitis, affecting about 620,000 Americans, causes inflammation and ulcers in the large intestine. This can lead to abdominal discomfort, bleeding and diarrhea, the FDA said in a news release. Crohn's causes inflammation and irritation of any part of the gastrointestinal tract. More than 500,000 Americans have been diagnosed with Crohn's, the FDA said. The most common side effects of Entyvio include headache, joint pain, nausea and fever. More serious adverse reactions observed during clinical testing ... Read more

Related support groups: Crohn's Disease, Ulcerative Colitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance

FDA Approves Simponi to Treat Ulcerative Colitis

Posted 15 May 2013 by Drugs.com

May 15, 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 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 ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Simponi, Ulcerative Colitis - Maintenance, Golimumab

Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product Delzicol

Posted 6 Feb 2013 by Drugs.com

DUBLIN, Ireland, Feb. 5, 2013 – Warner Chilcott plc today announced that the United States Food and Drug Administration (FDA) has approved its new 400 mg mesalamine product indicated for the treatment of ulcerative colitis. The product will be marketed as Delzicol (mesalamine) 400 mg delayed-release capsules. The Company anticipates that it will commercially launch Delzicol in March 2013. About Delzicol Delzicol (mesalamine) delayed-release capsules are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis. For information on dosage and administration, contraindications, warnings and precautions, adverse reactions, and other important safety information, please see the prescribing information. The Company Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Ulcerative Colitis - Maintenance, Mesalamine

Mouse Study Suggests Certain Fats Could Trigger Crohn's, Colitis

Posted 13 Jun 2012 by Drugs.com

WEDNESDAY, June 13 – Certain types of saturated fats common in today's Western diet may change gut bacteria and trigger inflammatory bowel disease in people genetically predisposed to the disorder, according to a new study that looked at this relationship in mice. Inflammatory bowel disease includes ulcerative colitis and Crohn's disease. The University of Chicago researchers said their findings help explain why once rare immune-system-related disorders such as inflammatory bowel disease have become more common in the United States and other Westernized nations in the last half-century. The researchers said their study may shed some light on why many people who are genetically prone to the condition still don't develop it and how certain environmental factors can cause inflammation in those at risk. Scientists note, however, that research with animals often fails to provide similar ... Read more

Related support groups: Crohn's Disease, Colitis, Ulcerative Colitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance

Chronic Bowel Disease Drugs Linked to Skin Cancer Risk

Posted 23 Nov 2011 by Drugs.com

TUESDAY, Nov. 22 – Some patients with inflammatory bowel disease may be at increased risk for skin cancer due to their use of immunosuppressant drugs to treat the intestinal disorder, according to the results of two new studies. The studies, published in the November issue of the journal Gastroenterology, noted that immunosuppressants are commonly used to treat patients with inflammatory bowel disease, or IBD. Currently, there are no specific recommendations for skin cancer screening in IBD patients. In one study, French researchers led by Dr. Laurent Peyrin-Biroulet, of University Hospital of Nancy, found that both past and present use of a widely used class of immunosuppressants called thiopurines significantly increased the risk of non-melanoma skin cancer in irritable bowel disease patients. "The increased risk of skin cancer that we found in our study was observed in all patients, ... Read more

Related support groups: Crohn's Disease, Colitis, Ulcerative Colitis, Crohn's Disease - Maintenance, Basal Cell Carcinoma, Ulcerative Colitis - Active, Inflammatory Bowel Disease, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Squamous Cell Carcinoma

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