FDA approves drug for severe asthma

GSK announced in a statement this morning that the FDA had approved its drug mepolizumab, marketed as Nucala, for use in combination with other therapies for patients 12 and older who have a history of severe asthma attacks.

Mepolizumab is a drug that targets the underlying cause of a form of the disease caused by eosinophilic inflammation, so it can only be used to treat specific cases that are brought on by this type of inflammation.

London-based GSK filed a biologics license application (BLA) in November 2014, seeking approval of the drug as an add-on maintenance therapy for patients with severe asthma with eosinophilic inflammation as identified by a blood eosinophil count of at least 150 cells per microliter at the start of treatment or 200 cells per microliter in the past 12 months.

More than 25 million people in the United States have asthma, a chronic condition, and about 5% can not achieve symptom control with existing therapies. But the drug can help many patients bring their severe asthma under control while still on their regular medication. It is administered alongside the patient’s regular treatment in the form of a subcutaneous injection in the upper arm, abdomen or thigh once every four weeks. Patients will receive Nucala in addition to their normal medications for severe asthma.

He concludes: “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”, Dube added.

Data indicated that patients with severe asthma receiving mepolizumab exhibited fewer exacerbations requiring hospitalization and/or ED visits and experienced longer time to the first exacerbation, compared with placebo. It does not, however, improve lung function, as measured by the volume of air exhaled by patients in one second.

Common adverse events associated with mepolizumab included headache, injection site reactions, back pain and fatigue. Hypersensitivity reactions can happen 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 mepolizumab.