(ABM FN-Dow Jones) Galapagos has received Orphan Drug Status, or orphan drug status, from the US regulator FDA and the European Commission for Ziritaxestat. Galapagos announced this.
This gives Galapagos market exclusivity for a period of seven to ten years for the treatment of autoimmune disease scleroderma with Ziritaxestat.
Furthermore, the legal costs are also reduced, and it gives access to the centralized marketing authorization procedure.
“We are pleased that the FDA and the EC recognize GLPG1690 as a potential new treatment for SSc patients. Now that the NOVESA Phase 2 study on SSc has been fully recruited, we expect the first results to be achieved in the second half of the year, ”said Chief Medical Officer Walid Abi-Saab of Galapagos.
Update: to add more information.
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