Glaxo pulls its EU app for rare disease therapy

GlaxoSmithKline says it reluctantly decided to pull its EU application for Bosatria (mepolizumab) after concluding that it didn't have the kind of efficacy data needed to make its case that the drug would help patients with hypereosinophilic syndrome. HES is a rare blood disorder characterized by the buildup of white blood cells, called eosinophil, which leads to fever, cardiac and respiratory problems and sometimes death.

The drug is designed to inhibit interleukin-5, which would reduce the supply of eosinophil. That same mechanism of action could be effective in treating particularly hard to control cases of asthma. And Glaxo says that it is continuing clinical development work in that field.

In its letter, the company said its decision to withdraw the application for Bosatria "was based on the CHMP's view that the data available to date did not allow the Committee to conclude on a positive benefit-risk balance for Bosatria in the applied indication."

- check out GSK release
- read the report from Reuters