Galapagos gets orphan drug designation in EU for GLPG1690 in idiopathic pulmonary fibrosis
Tuesday, September 06, 2016
Galapagos announces today that the European Commission (EC) has granted GLPG1690 ‘orphan drug designation’ for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
IPF is a chronic progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. The prevalence of IPF is fewer than 30 per 100,000 persons in both Europe and the United States, and as such, IPF is considered a rare disease. Currently, no medical therapies have been found to cure IPF.
In order to stimulate the pharmaceutical industry to develop and market medicines for a small number of patients, the EC offers a range of incentives to encourage the development of these ‘orphan’ medicines for rare diseases in the European Union. These incentives include protocol assistance, i.e. scientific advice specific for designated orphan medicines, and 10 years of market exclusivity once the medicine is on the market. Orphan designated medicinal products also benefit from regulatory fee reductions and access to the centralized procedure for marketing authorization.
“We are happy to see that the EC recognizes the potential of GLPG1690 as a new treatment for IPF-patients in Europe. Next step will be the application for orphan drug designation with the Food and Drug Administration (FDA) in the US,” said Piet Wigerinck, CSO of Galapagos.
GLPG1690 is currently being investigated in FLORA, a randomized, double blind, placebocontrolled Phase 2a study for 12 weeks in 24 IPF patients. Galapagos expects to report topline results in Q2 2017. GLPG1690 is a small molecule inhibitor of autotaxin and is fully proprietary to Galapagos.
Today at 16.30 CET hours, Galapagos is presenting ‘Strong reversal of the lung fibrosis disease signature by autotaxin inhibitor GLPG1690 in a mouse model for IPF’ at the European Respiratory Society Congress in London.
Source : glpg.com
