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FDA Approves Nucala to Treat Asthma Symptoms

The U.S. Food and Drug Administration (FDA) recently approved the use of Nucala (mepolizumab) in treating asthma in patients 12 years and older. Nucala (mepolizumap) is recommended for use alongside other asthma medications for the treatment and management of asthma, particularly for patients with a history of severe asthma attacks for whom other medications may have been ineffective.

Asthma is a chronic condition in which airways of the lungs become inflamed, causing shortness of breath, chest pain, and difficulty breathing. Airways narrow during an asthma attack which may result in hospitalization and even life-threatening situations. The Centers for Disease Control and Prevention reported that as of 2013, over 22 million Americans have asthma resulting in more than 400,000 hospitalizations related to asthma each year. The newly-approved use of Nucala may help patients to avoid such hospitalizations and provide significant relief of asthma symptoms.

How Nucala is Administered

A health care professional inserts a dosage of Nucala into the upper arm of the patient, abdomen, or thigh once every four weeks. Nucala is a humanized interleukin-5 antagonist monoclonal antibody. It is produced by recombinant DNA technology in the ovary cells of Chinese hamsters. Nucala reduces the levels of white blood cells called eosinophils. Because these white blood cells contribute to asthma symptoms, the reduction of these cells may also reduce severe asthma attacks.

Safety of Nucala

Nucala was approved as safe for use in asthma patients through tree double-blind, pacebo-controlled, randomized trials. The trials were conducted treating patients for whom other available therapies were ineffective in managing their severe asthma. Either Nucala or a placebo was given to patients as an additional asthma treatment during the course of these trials. The Nucala or placebo was administered once every four weeks. Patients who received Nucala were found to have fewer asthma attacks requiring hospitalization than those who received the placebo. Patients who received Nucala also used less of their daily maintenance oral corticosteroid dose and had better asthma control than those who received the placebo. Treatment using Nucala did not result in significant improvement in lung function when measured by volume of air exhaled by patients per second.

Side Effects of Nucala

The most common side effects reported with Nucala include injection site reactions such as pain, redness, swelling, itching, or burning, and symptoms including headaches, back pain, weakness, and fatigue. Hypersensitive reactions such as swelling of the face, mouth, and tongue, dizziness, lightheadedness, or fainting, hives, breathing problems, and rash may occur within hours or days of receiving Nucala. Infections of herpes zoster (the virus which causes shingles) were reported in some patients who received Nucala.

Nucala is made by GlaxoSmithKline, in Research Triangle Park, North Carolina.

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