MONMOUTH JUNCTION, NJ -- (Marketwired) -- 02/10/14 -- Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has issued a positive opinion on the Company's application for orphan designation for ARIKACE®, the Company's liposomal amikacin for inhalation, for the treatment of lung disease caused by nontuberculous mycobacteria (NTM). Orphan drug designation in the European Union (EU) is given to products that are designed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or chronically debilitating.
I must have missed it, thanks. I knew they released the COMP opinion in favor of orphan in February, but the EC did not grant it until last week (4/8). I could not find that and wondered if it being missing was due to some quiet period.