Insmed has announced that the EMA’s Committee for Orphan Medicinal Products has issued a positive opinion regarding orphan designation for Insmed’s Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The company says that it plans to report top line results from a Phase 2 trial of Arikace for NTM lung disease by the end of the first quarter of this year.
Insmed President and CEO Will Lewis commented, “The EMA’s orphan drug designation represents another step forward in our progress towards bringing this important therapy to the approximately 30,000 patients in the European Union in need of an effective therapy to treat NTM lung disease. We have already commenced the Scientific Advice Working Party process with the EMA to discuss a regulatory path forward for Arikace to treat NTM lung disease in Europe. We are actively developing a strategy to commercialize Arikace globally in this uncontested orphan disease market, and the EMA’s decision is an important milestone in support of these efforts.”
Arikace received orphan drug designation in the US in April 2013.
Read the Insmed press release.
