生物制药公司Atossa Genetics Inc近日宣布，其研发的药物(Z)-Endoxifen已获得美国食品药品监督管理局（FDA）授予的孤儿药认定，适应症为杜氏肌营养不良症（Duchenne Muscular Dystrophy）。这一里程碑式的进展为该药物后续研发及商业化铺平了道路。
孤儿药认定是FDA为鼓励开发用于治疗罕见疾病的药物而设立的特殊资格。获得该认定后，Atossa Genetics Inc将在药物获批后享有七年的市场独占权、税收抵免、临床试验费用补贴等多项政策支持。公司表示，将继续推进(Z)-Endoxifen的临床研究，力争早日为杜氏肌营养不良症患者提供新的治疗选择。
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