GSK says long-term study for Nucala backs safety profile
pharmafile | March 8, 2016 | News story | Manufacturing and Production, Research and Development | GSK, GlaxoSmithKline, Nucala, asthma
UK pharma major GlaxoSmithKline (LSE: GSK) said its asthma drug, Nucala (mepolizumab) showed a similar safety profile in a long-term study compared with previous studies.
The drug is already approved in the US and Europe.
Frank Albers, Global Medical Affairs Lead for Nucala, GSK said, “Severe asthma with an eosinophilic phenotype is a chronic condition that affects a small, but significant, number of patients who need to take multiple medications to control their day-to-day symptoms and reduce the risk of frequent and serious asthma attacks. As a first-in-class anti-IL-5 biologic therapy, Nucala was specifically developed for these difficult-to-treat patients. Results from Cosmos support the long-term safety profile and durability of response for Nucala and further our understanding of this novel therapeutic approach.”
The primary objective of the study was to describe the safety profile of long-term mepolizumab treatment, the company said in a statement. Findings from the trial showed the safety profile of mepolizumab was similar to that reported in the previous Phase III randomised studies.
GSK said Nucala maintained its risk/ benefit profile over an extended 52-week period. The drug was administered once every four weeks by injection. The trial product is an antibody that lowers the levels of eosinophils, similar to white blood cells that can cause asthma.
If over produced, eosinophils can lead to inflammation of lungs, thereby heightening the frequency of asthma attacks.
Anjali Shukla
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