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FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children

Posted 8 Jul 2016 by Drugs.com

South San Francisco, CA – July 7, 2016 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) to treat moderate to severe persistent asthma in children six to 11 years of age who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids4. Xolair is already approved to treat people 12 years and older with allergic asthma. "Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With this approval, we’re pleased to see a proven treatment option is now available for appropriate patients six and ... Read more

Related support groups: Asthma, Xolair, Omalizumab

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by Drugs.com

THURSDAY, Nov. 12, 2015 – Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests. Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues. For the study, published in the Nov. 12 online edition of the Journal of the American Society of Nephrology, the researchers looked at data from more than 200,000 U.S. kidney transplant candidates and recipients. Along with finding that these patients are at increased risk for certain types of cancer, the investigators also identified clear patterns of risk associated with different types of treatment. However, the associations seen in the study do not prove cause-and-effect. The risk of kidney and thyroid cancers was especially high when kidney failure patients were on ... Read more

Related support groups: Cancer, Methotrexate, Renal Failure, CellCept, Gilenya, Tysabri, Chronic Kidney Disease, Imuran, Xolair, Orencia, Revlimid, Arava, Leflunomide, Afinitor, Azathioprine, Tecfidera, Mycophenolate Mofetil, Peritoneal dialysis, Benlysta, Aubagio

FDA Medwatch Alert: Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

Posted 26 Sep 2014 by Drugs.com

ISSUE: An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label. The review found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label. BACKGROUND: Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines ... Read more

Related support groups: Asthma, Xolair, Omalizumab

Asthma Drug May Help Those With Chronic Hives

Posted 21 Jul 2014 by Drugs.com

MONDAY, July 21, 2014 – A drug already used to treat moderate-to-severe allergic asthma appears to offer relief to people with chronic hives who haven't been helped by standard medications, new research suggests. The prescription drug – omalizumab (Xolair) – is already available to treat hives, following U.S. Food and Drug Administration approval earlier this year for that use. The current study confirms that when Xolair is taken at a high dose for a six-month period it seems to be both safe and effective at controlling the severe and often debilitating itching that characterizes long-term hives. "So what we're talking about here are only chronic cases, in which patients have hives that last for more than six weeks," explained study senior author Dr. Karin Rosen, an associate group medical director with Genentech Inc., in San Francisco. "That's usually just .5 to 1 percent of hives ... Read more

Related support groups: Hives, Urticaria, Xolair, Omalizumab

FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria

Posted 24 Mar 2014 by Drugs.com

South San Francisco, Calif. – March 21, 2014 – Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy5. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response3. CIU is diagnosed when hives occur without an identifiable cause, spontaneously present, and reoccur for more than six weeks1,3. CIU can have burdensome symptoms including swelling, severe itch, pain, and discomfort that may last for many months and even years1,2. Approximately 1.5 million people in the U.S. develop CIU at some stage in their life3,4. Women are twice ... Read more

Related support groups: Urticaria, Xolair, Omalizumab

Options Increasing for Coping With Kids' Food Allergies

Posted 3 Aug 2012 by Drugs.com

FRIDAY, Aug. 3 – Kids with a serious food allergy generally have to steer clear of the offending food, but methods now under development could change that common scenario. More than 3 million American youths – about one of every 25 – have a food allergy of some sort, usually to milk, eggs or peanuts, according to U.S. government statistics. For them, "avoidance has been the mainstay of treatment for a long time," said Dr. William Silvers, an allergist in private practice in Vail, Colo., and a spokesman for the American College of Allergy, Asthma and Immunology. "Now what we're seeing is an increased interest in oral immunotherapy," Silvers said. "This means giving small and slowly increased doses orally of foods that children are allergic to, and building up the amount ingested over time to desensitize the child to the food so they can tolerate it." That doesn't come string-free, ... Read more

Related support groups: Allergies, Xolair, Omalizumab, Oral Allergy Syndrome

Xolair Reduces Seasonal Asthma Attacks for Inner City Kids: Study

Posted 16 Mar 2011 by Drugs.com

WEDNESDAY, March 16 – The injectable medication Xolair reduced asthma symptoms in inner city children with the respiratory condition, and almost eliminated seasonal peaks in asthma attacks, new research shows. When added to standard asthma treatments, Xolair (omalizumab) decreased the amount of inhaled steroid needed to maintain asthma control, according to the study, which is published in the March 17 issue of the New England Journal of Medicine. "Omalizumab improves asthma control on top of guidelines-based treatment," said study co-author Dr. William Busse, a professor of medicine at the University of Wisconsin School of Medicine in Madison. "There was less need for other medications, a reduction of symptoms and reduction of the seasonal exacerbations of asthma. Omalizumab almost totally eliminated these attacks." But, he added, it's too soon to make treatment recommendations based ... Read more

Related support groups: Asthma, Xolair, Omalizumab

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