GlaxoSmithKline (GSK) has withdrawn the marketing authorisation application in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES), following feedback from the Committee for Medicinal Products for Human Use (CHMP) that additional data was needed to further demonstrate clinical benefits.
Mepolizumab, an investigational, humanised monoclonal antibody, was intended for the treatment of FIP1 negative HES (HES patients without the FIPL1-PDGRA fusion gene), to reduce or eliminate the need for corticosteroid therapy and to reduce eosinophil count. There are currently no approved therapies in the EU for FIP1 negative HES.
GSK plans to continue, where permitted, to support access to mepolizumab for patients with life-threatening HES through its ongoing compassionate use programme. Patients will receive the drug for as long as they and their doctor believe they are benefiting from the treatment.
"Research and development in HES is tremendously challenging," said David Gordon, VP Biopharm R&D at GSK. "It is a disease with very limited treatment options and this decision has been extremely difficult to take. Nevertheless, we are committed to exploring new options to develop mepolizumab as a treatment for HES," he added.
Withdrawal of the EU application for mepolizumab for the treatment of HES does not preclude GSK from filing an application at a later date and the company will continue to explore future options for the development of the product. Development programmes for the other potential indications, including severe asthma will continue as planned.