Nucala Approved by FDA to Treat Patients with Severe Asthma

Nucala Approved by FDA to Treat Patients with Severe Asthma
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November 5, 2015

The U.S. Food and Drug Administration (FDA) has approved a new treatment option for individuals suffering from severe asthma.

The agency issued the approval for Nucala (mepolizumab). The drug is intended to be used with other asthma medicines for the maintenance treatment of asthma in patients aged 12 years and older. It is approved for patients who have a history of severe asthma attacks despite receiving their current asthma medicines.

"This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma," Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, said in a written statement.

Nucala is administered by injection monthly by a health care professional. It 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 efficacy of the drug was established through three controlled trials. 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.

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).

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.

Nucala is made by North Carolina pharmaceutical company GlaxoSmithKline.