The FDA has 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. Nucala is made by GlaxoSmithKline, in Research Triangle Park, North Carolina.
Asthma is a chronic disease that causes inflammation in the airways of the lungs. During an asthma attack, the 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 CDC, 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 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.
See the FDA Announcement
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See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication