PBR Staff Writer Published 07 March 2016 GlaxoSmithKline (GSK) said its asthma drug, Nucala, demonstrated a similar safety profile in a long-term study compared with previous trials.

Nucala, which is administered once every four weeks by injection, maintained its risk/benefit profile over an extended 52-week period.

The company enrolled a total of 651 patients in the open-label Cosmos (MEA115661) study. Of the total subjects, 414 had received mepolizumab in either the 32-week phase III Mensa (MEA115588) exacerbation study or the 24-week Sirius (MEA115575) steroid-reduction trial.

The study also included 237 patients who had received placebo in the earlier phase III trials.

GSK said for patients switching from placebo to mepolizumab, findings from COSMOS demonstrated similar improvements in asthma control to those in the mepolizumab arms of the earlier trials.

GSK global medical affairs lead for Nucala Frank Albers said: "Results from COSMOS support the long-term safety profile and durability of response for Nucala and further our understanding of this novel therapeutic approach."

Last November, the US Food and Drug Administration (FDA) approved Nucala as an add-on maintenance treatment for patients aged 12 and older.

The drug is a monoclonal antibody that inhibits interleukin-5 (IL-5), which helps regulate eosinophils, a type of white blood cell that contributes to asthma.

The over-production of eosinophils can lead to inflammation in the lungs, increasing the frequency of asthma attacks.

The European Commission has also granted marketing authorisation for Nucala as an add-on treatment for severe refractory eosinophilic asthma in adult patients.

Nucala is approved for use in the 31 European countries covered by the European Medicines Agency.



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