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FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade

Posted 27 Apr 2017 by Drugs.com

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis. Renflexis is the first Samsung Bioepis product approved for marketing in the United States (US). “Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the United States by offering them treatment options at a lower cost. We hope this regulatory milestone will bring us a step closer to achievin ... Read more

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

New Meds Make Inroads Against Crohn's Disease

Posted 13 Apr 2017 by Drugs.com

THURSDAY, April 13, 2017 – Fewer Americans with Crohn's disease are ending up in the hospital than in the past, according to a new federal study. Crohn's is a chronic inflammatory bowel disorder that often leads to surgery for most with the disease. Hospitalization rates for Crohn's disease remained stable in the United States between 2003 and 2013. That's a change from a study done from 1998 to 2004 that saw more than 4 percent increases in Crohn's hospitalizations each year, researchers with the U.S. Centers for Disease Control and Prevention said. The stable hospital rates are likely due to the 1998 introduction of a new class of biologic drugs. Examples of these medications used to treat Crohn's disease include: adalimumab (Humira), infliximab (Remicade), certolizumab (Cimzia) and ustekinumab (Stelara), according to the U.S. National Institute of Diabetes and Digestive and Kidney ... Read more

Related support groups: Humira, Crohn's Disease, Remicade, Ulcerative Colitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Inflammatory Bowel Disease, Stelara, Cimzia, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Adalimumab, Inflectra, Certolizumab, Ustekinumab, Amjevita

Family History of Colon Cancer Calls for Earlier Screening

Posted 21 Mar 2017 by Drugs.com

TUESDAY, March 21, 2017 – If you've got a family history of colon or rectal cancers, you probably need to start screening for these conditions before you turn 50, a cancer expert says. People with a close relative who has had colon or rectal cancer have a greater risk of being diagnosed with these cancers too, said Dr. Walter Koltun, chief of colon and rectal surgery at the Penn State Health Hershey Medical Center in a hospital news release. "A significant portion of the population does have those risk factors," Koltun said. "And their risk goes up significantly depending on who has been affected." If more than one close relative has had colon or rectal cancer, your risk of getting such a cancer is 12 times greater, he added. People who are diagnosed with colon or rectal cancers at a young age are more likely to have a genetic trait that could increase their risk for the disease. ... Read more

Related support groups: Cancer, Breast Cancer, Crohn's Disease, Colonoscopy, Prostate Cancer, Colorectal Cancer, Inflammatory Bowel Disease, History - Radiation Therapy

Common Virus May Be Linked to Heart Disease, Diabetes in Some Women

Posted 23 Feb 2017 by Drugs.com

THURSDAY, Feb. 23, 2017 – A common virus may make some women more susceptible to both heart disease and type 2 diabetes, a new study suggests. Scientists at the University of California, San Francisco found normal-weight women under age 50 who were infected with cytomegalovirus (CMV) were more likely to have metabolic syndrome than their peers. Metabolic syndrome is a collection of risk factors for heart disease and diabetes that includes excess belly fat, unhealthy cholesterol levels, high blood pressure and high blood sugar levels. CMV, a herpes virus, is believed to infect roughly half of the U.S. population over the age of 40. Typically there are no symptoms unless the person's immune system is weakened. Ironically, obese women infected with CMV were less likely to have metabolic syndrome than obese women not infected with the virus, the researchers found. However, obese women were ... Read more

Related support groups: Diabetes, Type 2, Heart Disease, High Cholesterol, Crohn's Disease, Insulin Resistance, Crohn's Disease - Maintenance, Pre-Diabetes, Inflammatory Bowel Disease, Crohn's Disease - Acute, Viral Infection, Cytomegalovirus (CMV) Infection, Ulcerative Proctitis, Ischemic Heart Disease, CMV Pneumonia, CMV Retinitis, CMV Gastroenteritis

Special Diet May Be Boon for Kids With Crohn's, Colitis

Posted 10 Jan 2017 by Drugs.com

MONDAY, Jan. 9, 2017 – Children with Crohn's disease and ulcerative colitis may be able to achieve relief without medications by eating a special diet, a small study suggests. The diet includes non-processed foods, such as fruits, vegetables, meats and nuts. Over 12 weeks, the diet appeared to ease all signs of these inflammatory bowel diseases in eight of the 10 affected children, researchers report. "The study shows that without other intervention, other changes, we can improve individuals' clinical as well as laboratory markers," said study author Dr. David Suskind. He's a professor of pediatrics and director of clinical gastroenterology at Seattle Children's Hospital. "I'm not surprised," Suskind added, "primarily because preliminary studies ... opened our eyes to the idea that diet had an impact." Inflammatory bowel disease (IBD) affects about 1.6 million Americans, according to ... Read more

Related support groups: Crohn's Disease, Dietary Supplementation, Colitis, Ulcerative Colitis, Asacol, Crohn's Disease - Maintenance, Creon, Sulfasalazine, Ulcerative Colitis - Active, Inflammatory Bowel Disease, Pentasa, Lialda, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Lactaid, Apriso, Mesalamine, Pancrease, Zenpep, Canasa

Drug Stelara May Ease Crohn's Disease

Posted 18 Nov 2016 by Drugs.com

THURSDAY, Nov. 17, 2016 – People with moderate to severe Crohn's disease who haven't responded to other treatments may benefit from the drug ustekinumab (Stelara), a new study suggests. Stelara is a monoclonal antibody that blocks the action of the inflammatory agents interleukin-12 and interleukin-23. The drug had been approved for the treatment of psoriasis and is now approved for treating Crohn's disease as well. Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract. Crohn's usually affects the end of the small bowel and the beginning of the colon. But it may affect any part of the gastrointestinal tract, from the mouth to the anus, according to the Crohn's and Colitis Foundation of America (CCFA). Crohn's can cause diarrhea, rectal bleeding, an urgent need to move the bowels, stomach cramps, pain and constipation, the CCFA says. "Stelara is effective for ... Read more

Related support groups: Humira, Crohn's Disease, Remicade, Crohn's Disease - Maintenance, Stelara, Cimzia, Crohn's Disease - Acute, Ustekinumab

The Scoop About Healthy Poop

Posted 25 Oct 2016 by Drugs.com

TUESDAY, Oct. 25, 2016 – Your bowel movements can offer important clues about your health, a doctor says. If bowel movements feel comfortable, then it's likely all is well, said Dr. Gabriel Neal, a family medicine doctor and clinical assistant professor at Texas A&M College of Medicine. "Normal bowel movements are relatively soft but dense. They should be any shade of brown or green," Neal said in a college news release. Viruses and bacteria in the intestinal tract can cause stool discoloration, diarrhea or blood in the stool. The color of the blood can help your doctor pinpoint the location of the infection. "If an infection is in the lower intestines or colon, then the blood in your stool is going to be red. If you find black blood, then the blood has oxidized and is from higher up in your digestive tract, such as the stomach or upper intestines," Neal said. People with gallbladder ... Read more

Related support groups: Diarrhea, Constipation, Crohn's Disease, Constipation - Chronic, Gastrointestinal Disorders, Inflammatory Bowel Disease, Gallbladder Disease, Constipation - Acute, Diarrhea, Chronic, Diarrhea, Acute, Infectious Diarrhea

Study Identifies Genetic Subtypes of Crohn's Disease

Posted 14 Oct 2016 by Drugs.com

FRIDAY, Oct. 14, 2016 – Crohn's disease appears to have at least two distinct genetic subtypes, which could explain why the condition is so hard to treat, a new study suggests. "The one-treatment-fits-all approach doesn't seem to be working for Crohn's patients," said study co-senior author Dr. Shehzad Sheikh. He's an assistant professor in the departments of medicine and genetics at the University of North Carolina School of Medicine. "It's plausible that this is because only a subset of patients has the type of disease that responds to standard therapy, whereas, for the rest of the patients, we're really not hitting the right targets," Sheikh said in a university news release. Crohn's is a chronic inflammatory disorder of the intestinal tract. The most common symptoms are diarrhea, stomach cramps and weight loss. The course and severity of the disease vary widely from patient to ... Read more

Related support groups: Humira, Crohn's Disease, Asacol, Crohn's Disease - Maintenance, Sulfasalazine, Inflammatory Bowel Disease, Pentasa, Lialda, Stelara, Crohn's Disease - Acute, Apriso, Mesalamine, Canasa, Azulfidine, Delzicol, Asacol HD, Sulfazine, Diagnosis and Investigation, Rowasa, Azulfidine EN-tabs

FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease

Posted 27 Sep 2016 by Drugs.com

HORSHAM, Pa., Sept. 26, 2016 /PRNewswire/ – Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. Stelara is the first biologic therapy for Crohn's disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses. "Crohn's disease is a complex condition to treat, and not all therapies work for every patient," said William J. Sandborn, MD, Chief, Division of Gastroenterology, and Professor of Medicine, UC San Diego School of Medicine, and ... Read more

Related support groups: Crohn's Disease, Stelara, Ustekinumab

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, Ulcerative Colitis, Psoriatic Arthritis, 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, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Maintenance, Adalimumab, Amjevita

Smoking Linked to Higher Relapse Risk After Surgery for Crohn's

Posted 2 Sep 2016 by Drugs.com

THURSDAY, Sept. 1, 2016 – Smoking increases the risk that Crohn's disease patients will have relapses after bowel surgery, new research suggests. The study included 240 Crohn's disease patients in the United Kingdom who were followed for three years after bowel surgery. Crohn's disease occurs when the immune system attacks the lining of the gut and bowel, and causes severe inflammation, the study authors noted. This can result in diarrhea, abdominal pain, nausea and reduced appetite. Patients are usually initially treated with drugs to suppress their immune system. But the study authors said that more than half of Crohn's patients eventually have surgery to remove the affected section of their bowel. However, surgery does not cure Crohn's, and relapses are common. According to the researchers from the University of Edinburgh in Scotland, smokers were much more likely than nonsmokers to ... Read more

Related support groups: Surgery, Smoking, Crohn's Disease, Smoking Cessation, Crohn's Disease - Maintenance, Crohn's Disease - Acute

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, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Plaque Psoriasis, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Inflectra

FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade

Posted 7 Apr 2016 by Drugs.com

April 5, 2016 – The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis (arthritis of ... Read more

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

Health Tip: Get Enough Nutrients

Posted 14 Jan 2016 by Drugs.com

-- A nutritious diet is especially important for people with irritable bowel disease (IBD), since they may be at increased risk of malnutrition. The Crohn's and Colitis Foundation of America says possible benefits of a nutritious diet include: Fewer symptoms of IBD. Reduced risk of iron or calcium deficiency. Improved bone health. Healthier body weight. Better regulation of hormone levels in girls and women. Read more

Related support groups: Irritable Bowel Syndrome, Crohn's Disease, Crohn's Disease - Maintenance, Crohn's Disease - Acute

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