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Galapagos Announces FDA and EU Orphan Drug Designation for GLPG1690 in Systemic Sclerosis

Galapagos NV (NASDAQ: GLPG) announces today that the US Food & Drug Administration (FDA) and the European Commission (EC) have granted investigational autotaxin inhibitor GLPG1690 ‘orphan drug designation' for the treatment of systemic sclerosis (SSc).

Benzinga · 01/29/2020 10:12

Galapagos NV (NASDAQ: GLPG) announces today that the US Food & Drug Administration (FDA) and the European Commission (EC) have granted investigational autotaxin inhibitor GLPG1690 ‘orphan drug designation' for the treatment of systemic sclerosis (SSc).

In order to stimulate the pharmaceutical industry to develop and market medicines for diseases affecting a small number of patients, the EC and the FDA offer a range of incentives to encourage the development of these ‘orphan' medicines for rare diseases in the European Union and the United States. These incentives include amongst others 7 to 10 years of market exclusivity once the medicine is on the market, regulatory fee reductions and fee waivers and access to the centralized procedure for marketing authorization in Europe.1,2

"We are happy to see that the EC and FDA recognize GLPG1690 as a potential new treatment for SSc patients. With the NOVESA Phase 2 trial in SSc fully recruited, we expect to see topline data in the second half of the year," said Dr. Walid-Abi-Saab, CMO of Galapagos.