- GlaxoSmithKline's Nucala (mepolizumab) is an injectable IL-5 monoclonal antibody designed to treat severe asthma in patients who are non-responsive to high-dose inhaled corticosteroids.
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the data on Nucala for four days, and issued a recommendation based on the stength of strong phase 3 outcomes in patients with severe refractory eosinophilic asthma.
- A final decision on Nucala is expected by the end of the year.
Thus far, Nucala has not been approved anywhere in the world. But it is also under review in the U.S., where it has been recommended for approval, and in Japan.
There are a group of patients with severe asthma whose disease cannot be controlled, even when they are treated with high-dose inhaled corticosteroids plus another maintenance treatment. For these patients, Nucala could represent an important treatment option.
GSK, which is heavily focused on reviving its respiratory therapeutics roster, is not the only company developing biologic, IL-5 based treatments for asthma. Other companies involved in similar R&D include AstraZeneca, Roche, Teva, and Sanofi.
Glaxo took a big blow earlier this month when its COPD/asthma medication Breo Ellipta, sometimes called the "Son of Advair," did not show the overall survival benefit for COPD patients that Glaxo was hoping it would.