Galapagos: EC Grants GLPG1690 Orphan Drug Designation To Treat IPF Patients

(RTTNews) - Galapagos NV (GLPG) announced Tuesday that the European Commission has granted GLPG1690 'orphan drug designation' for the treatment of patients with idiopathic pulmonary fibrosis or 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 is considered a rare disease. Currently, no medical therapies have been found to cure IPF.

GLPG1690 is currently being investigated in FLORA, a randomized, double blind, placebo-controlled Phase 2a study for 12 weeks in 24 IPF patients. Galapagos expects to report topline results in second quarter 2017. GLPG1690 is a small molecule inhibitor of autotaxin and is fully proprietary to Galapagos.

The EC offers a range of incentives to encourage the development of 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.

Piet Wigerinck, CSO of Galapagos, said, "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 in the US."