Press Release: FDA approves Nucala to treat severe asthma

FDA NEWS RELEASE

For Immediate Release: Nov. 4, 2015

Media Inquiries: Eric Pahon, 240-402-4177, [e-mail]

Consumer Inquiries: 888-INFO-FDA

FDA approves Nucala to treat severe asthma

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 therapy when current treatments cannot maintain adequate control of their asthma," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

Nucala is administered once every four weeks by subcutaneous injection by a health care professional into the upper arm, thigh, or abdomen. Nucala is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells. Nucala reduces severe asthma attacks by reducing the levels of blood eosinophils- a type of white blood cell that contributes to the development of asthma.

The safety and efficacy of Nucala were established in three double-blind, randomized, placebo controlled trials in patients with severe asthma on currently available therapies. Nucala or a placebo was administered to patients every four weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalization and/or emergency department visits, and a longer time to the first exacerbation. In addition, patients with severe asthma receiving Nucala experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control compared with patients receiving placebo. Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.

The most common side effects of Nucala include headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness (fatigue). Hypersensitivity reactions can occur within hours or days of being treated with Nucala, including swelling of the face, mouth, and tongue; fainting, dizziness, or lightheadedness; hives; breathing problems and rash. Herpes zoster infections have occurred in patients receiving Nucala. Herpes zoster is the virus that causes shingles.

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

For more information:

   •   FDA Center for Drug Evaluation and Research: Drug Information 
   •   Centers for Disease Control and Prevention: Asthma 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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November 04, 2015 17:30 ET (22:30 GMT)

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