普利製藥(300630.SZ):拉考沙胺注射液獲得美國食品藥品監督管理局(FDA)上市許可
格隆匯2月18日丨普利製藥(300630.SZ)公佈,公司於近日收到美國食品藥品監督管理局(簡稱“FDA”)簽發的拉考沙胺注射液的上市許可。適應症為(1)4歲及以上患者部分發作性癲癇的治療;(2)4歲及以上患者原發性全身性強直-陣攣性癲癇的輔助治療。
拉考沙胺是一系列功能性氨基酸中的一種,在不同的臨牀前模型和臨牀研究中顯示出具有抗癲癇作用。在體外電生理研究表明,拉考沙胺選擇性增加電壓門控鈉通道的慢失活,導致對過度興奮的神經元細胞膜的穩定作用。
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