MHLW approves GSK’s Nucala in Japan

GlaxoSmithKline (GSK) announced last week the approval of Nucala (mepolizumab) by the Japanese Ministry of Health Labor and Welfare (MHLW).

Nucala was developed for the treatment of bronchial asthma in patients suffering from refractory asthma who did not respond to the standard measure of treatment. Nucala is currently licensed in Japan for patients who are 12 years of age or older.

Nucala is the first developed biologic medication in a new class of anti-interleukin-5 (IL-5) therapies. IL-5 is used to stymie eosinophils, which are inflammatory white blood cells that are a significant in asthma. Nucala is administered to patients once over a four-week period as a subcutaneous injection with a fixed dosage of 100 mg. The treatment will be provided to patients as an add-on to their respiratory medication.

Nacula’s Japan approval comes after the medication was approved in the United States four months ago. The Japan approval marks the first time the anti-IL-5 treatment has been approved on an international scale.

The MHLW review of mepolizumab was centered on data from a worldwide clinical development program. The program included the DREAM, MENSA and SIRIUS studies, all of which researched the efficiency and safety of mepolizumab.