The FDA has approved GlaxoSmithKline's mepolizumab (Nucala) as an add-on maintenance treatment for severe asthma.
The FDA has approved GlaxoSmithKline’s mepolizumab (Nucala) as an add-on maintenance treatment for patients ages 12 and older with severe asthma.
The drug is administered once every 4 weeks by subcutaneous injection by a health care professional into the upper arm, thigh, or abdomen. The first interleukin-5 antagonist therapy to receive the FDA’s nod, Nucala reduces severe asthma attacks by reducing the levels of blood eosinophil levels in the blood.
“Our research has allowed us to better understand the specific role eosinophils play in severe asthma,” said GlaxoSmithKline senior vice president Eric Dube in a press release. “We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible.”
In June, the FDA’s Pulmonary Allergy Drugs Advisory Committee recommended the drug’s approval for adults with severe asthma in a 14-0 vote, but it voted 4-10 against its use in adolescents ages 12 to 17, noting that the drug's efficacy and safety in this population had not yet been adequately demonstrated.
The agency ultimately based its decision on data from 3 late-stage trials in which patients with severe asthma were given Nucala or placebo every 4 weeks. Compared with those who received placebo, asthma patients treated with Nucala had fewer exacerbations requiring hospitalization or visits to the emergency department, as well as a longer time to the first exacerbation.
Additionally, patients in the Nucala group experienced greater reductions in their daily maintenance oral corticosteroid dose while maintaining asthma control compared with patients receiving placebo. However, the drug’s use did not yield a significant improvement in lung function.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” stated Badrul Chowdhury, MD, PhD, director of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.
The most common adverse events reported by trial patients treated with Nucala include headache, injection site reactions, back pain, and fatigue. Hypersensitivity reactions—including swelling of the face, mouth, or tongue, fainting, dizziness, lightheadedness, hives, breathing problems, and rash—were observed within hours or days of treatment with the drug. Herpes zoster infections have also occurred in patients receiving Nucala.
The FDA is currently considering whether to expand the drug’s indication to include the the treatment of adults with severe chronic obstructive pulmonary disease (COPD).