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FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)

Posted 2 days 6 hours ago by Drugs.com

December 12, 2017 – The U.S. Food and Drug Administration today expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA. According to the National Institutes of Health, EGPA (formerly known as Churg-Strauss syndrome) is a condition characterized by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small- to medium-sized blood vessels. The inflamed vessels can affect various organ systems including the lungs, gastrointestinal tract, skin, heart and nervous system. It is estimated that approximately 0.11 to 2.66 new cases per 1 million people are diagnosed ... Read more

Related support groups: Nucala, Mepolizumab, Churg-Strauss Allergic Angiitis

First Drug, Nucala (Mepolizumab), Approved for Rare Eosinophilic Granulomatosis With Polyangiitis

Posted 3 days ago by Drugs.com

TUESDAY, Dec. 12, 2017 – Nucala (mepolizumab) has been approved by the U.S. Food and Drug Administration as the first remedy to treat adults with eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that leads to inflammation of the blood vessels. Other symptoms of the condition, formerly called Churg-Stress syndrome, include asthma and an overabundance of an infection-fighting white blood cell called an eosinophil. The inflamed blood vessels may affect the lungs, intestines, skin, heart and nervous system. The condition affects a total of about 11 out of every one million people in United States, the FDA said Tuesday in a news release. "Patients taking Nucala in clinical trials reported a significant improvement in their symptoms," said Dr. Badrul Chowdhury, director of the FDA's Division of Pulmonary, Allergy and Rheumatology Products. Nucala, a once-monthly ... Read more

Related support groups: Autoimmune Disorders, Nucala, Mepolizumab, Chronic Granulomatous Disease

New Biologic Drug Tackles Hard-to-Control Asthma

Posted 7 Sep 2016 by Drugs.com

WEDNESDAY, Sept. 7, 2016 – A new injectable drug reduces flare-ups in patients with severe asthma that is not controlled by steroid inhalers alone, two new trials show. The drug, benralizumab, is a biologic that works by killing white blood cells called eosinophils. These are present in large numbers in such patients, and they have been linked to severe asthma. If approved by the U.S. Food and Drug Administration, benralizumab would join two similar drugs – mepolizumab (Nucala) and reslizumab (Cinqair) – in fighting hard-to-control asthma, the researchers said. "We can offer patients who frequently require courses of oral corticosteroids and have a certain level of eosinophils [an allergy-related cell easily measured in the blood] a very effective treatment," said study author Dr. J. Mark FitzGerald. He is a professor of respiratory health at the University of British Columbia in ... Read more

Related support groups: Asthma, Asthma - Maintenance, Asthma - Acute, Nucala, Allergic Asthma, Cinqair, Mepolizumab, Reslizumab

FDA Approves Nucala (mepolizumab) to Treat Severe Asthma

Posted 4 Nov 2015 by Drugs.com

November 4, 2015 - The U.S. Food and Drug Administration today approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. Asthma is a chronic disease that causes inflammation in the airways of the lungs. During an asthma attack, airways become narrow making it hard to breathe. Severe asthma attacks can lead to asthma-related hospitalizations because these attacks can be serious and even life-threatening. According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the U.S. have asthma, and there are more than 400,000 asthma-related hospitalizations each year. “This approval offers patients with severe asthma an additional ... Read more

Related support groups: Asthma, Nucala, Mepolizumab

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Related Condition Support Groups

Asthma, Asthma - Maintenance, Churg-Strauss Allergic Angiitis

Nucala Patient Information at Drugs.com