New Biological Drug to Treat Asthma
The U.S. Food and Drug Administration (FDA) has approved Nucala® (mepolizumab) for use with other asthma medicines for the treatment of asthma in patients age 12 years and older. Nucala® is approved for patients who have a history of severe asthma attacks despite taking their current asthma medicines. Nucala® is considered a “maintenance” medication to prevent attacks and not a quick relief medication like albuterol.
What is asthma?
- Asthma is a chronic disease that causes inflammation in the airways of the lungs. Frequently that inflammation is triggered by eosinophils. During an asthma attack, small and medium size airways become narrow making it hard to breathe. Severe asthma attacks can lead to ER visits and hospitalizations because attacks can be serious and even life-threatening.
What is Nucala®?
- Nucala® is administered once every 4 weeks by subcutaneous injection (like an allergy shot) 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. To put that in English, Nucala® is an antibody (almost all human antibody) produced in hamster cells in a lab that blocks the effect of a messenger protein preventing the blood eosinophils which cause inflammation in the lung from living too long. 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.
Does Nucala® work?
- The safety and effectiveness of Nucala® were established in 3 double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies. Nucala® or a placebo was administered to patients every 4 weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Nucala® had fewer attacks requiring hospitalization and/or emergency room visits, and a longer time to the first asthma attack. In addition, patients with severe asthma receiving Nucala® experienced greater reductions in their daily maintenance oral steroid (like Prednisone) 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 (FEV1).
What are the potential side effects of Nucala®?
- 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 light-headedness; 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.
At Family Allergy & Asthma Care of Montana, we assess our patients with asthma to determine what the best treatment plan is specifically for them. With this new “biological” medication, the only blood test that needs to be done to determine if a patient is a candidate, is a CBC (Complete Blood Count) to assess if the eosinophil count is elevated. The second hurdle will be dealing with approval from health insurance companies, as these medications tend to be very expensive.