FDA Approves New Severe Asthma Treatment

Nucala is for use with other asthma drugs for the maintenance of patients 12 years and older.

The FDA today gave the thumbs up to a new treatment option for patients suffering from severe asthma.

Mepolizumab (Nucala) was approved for use with additional asthma therapies in the maintenance treatment of asthma in patients 12 years of age and older. The drug treats patients with a history of severe asthma exacerbations despite treatment with current asthma therapy regimens.

“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” said Badrul Chowdhury, MD, PhD, director of the FDA Division of Pulmonary, Allergy, and Rheumatology Products in the Center for Drug Evaluation and Research.

Severe asthma exacerbations can result in hospitalizations due to the serious and life-threatening nature of these attacks. The FDA noted that there are more than 400,000 annual hospitalizations related to severe asthma.

Nucala is administered by a caregiver once every 4 weeks via subcutaneous injection into the upper arm, thigh, or abdomen. The humanized interleukin-5 antagonist monoclonal antibody was produced by recombinant DNA technology from the cells of Chinese hamster ovaries, according to the FDA.

The drug decreases severe asthma attacks through a reduction of blood eosinophils levels, which is a type of white blood cell associated with asthma development.

Three double-blind, randomized, placebo‑controlled trials of patients with severe asthma on current treatment regimens showed the safety and efficacy of Nucala. Patients were administered either Nucala or a placebo every 4 weeks as an additional treatment.

Patients treated with Nucala experienced fewer exacerbations that required hospitalization and a longer timeframe to the first exacerbation compared with placebo.

Additionally, patients treated with Nucala saw greater reductions in their oral corticosteroid daily maintenance dose while maintaining asthma control compared with the placebo group.

Nucala treatment did not cause significant improvement in lung function measured by air volume exhaled by patients in 1 second. Common adverse events associated with Nucala include headache, injection site reactions, back pain, and fatigue.

Hypersensitivity reactions can occur within hours or days of starting Nucala treatment, including swollen face, mouth, and tongue; fainting, dizziness, or lightheadedness; hives, breathing problems, and rash.

Patients receiving Nucala may also experience herpes zoster infections, which can cause shingles.