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                您當前位置:網站首頁 >> 醫藥新聞 >> 行業動態 >> CHMP 推薦奧拉帕尼用于乳腺癌及 Dupixent 用于哮喘
               
               
              CHMP 推薦奧拉帕尼用于乳腺癌及 Dupixent 用于哮喘
              2019-03-07 13:05:31 來源:丁香園 瀏覽:3395

              PMLiVE 于 3 月 5 日報道,歐洲藥品管理局(EMA)藥品咨詢委員會(CHMP)推薦批準阿斯利康和默沙東的奧拉帕尼及賽諾菲 Dupixent 的新適應癥,而新的適應癥可能為這兩款藥物打開規模可觀的新市場。

              PARP 抑制劑奧拉帕尼已在卵巢癌方面已取得重大進展,CHMP 給予該藥物積極評價,支持其用于 BRCA 突變、HER2 陰性乳腺癌,這一適應癥一年剛剛在美國獲得 FDA 批準。根據 CHMP 的意見,在最初嘗試化療或激素治療后,奧拉帕尼可以作為單一療法使用,這取決于腫瘤的特點,除非這些療法不合適。

              去年,奧拉帕尼在美國的銷售額增長一倍多,達到 6.47 億美元,此前該藥物在美國獲批了乳腺癌適應癥,并擴展用于卵巢癌治療。阿斯利康和默沙東期望該藥物的銷量能進一步增長,若其適用范圍進一步擴大到胰腺癌,銷售增長的希望會更大。對于賽諾菲及其 Dupixent(dupilumab)的合作伙伴再生元來說,該 IL-4 和 IL-13 抑制劑作為重度哮喘輔助療法而獲得批準,被視為其實現數十億美元銷售預期的一個關鍵因素。

              Dupixent 去年被 FDA 批準用于哮喘,豐富了現有的過敏性皮膚炎適應癥,分析師們認為,新適應癥的獲批可能使該藥物的年銷售峰值達到 25 億美元,因為它可以減少高劑量吸入性糖皮質激素的使用,而如果長期使用吸入性糖皮質激素會有嚴重的副作用。

              在最近的一次會議上,CHMP 還給出了許多其他重要建議,包括一項是給予 Portola 旗下 Ondexxya(andexanet alfa),如果該藥物獲 EMA 完全批準,它將成為凝血因子 Xa 新型口服抗凝劑的首個逆轉劑。一年前該藥物曾被 CHMP 否決。Ondexxya 用于服用輝瑞/百時美施貴寶阿哌沙班片、拜耳/強生利伐沙班而出現危及生命或無法控制的出血患者。到目前為止,勃林格殷格翰的達比加群酯是市場上唯一有逆轉劑的新型口服抗凝劑。

              經 CHMP 最新討論,兩種罕見病藥物有望近期獲得歐盟批準。CHMP 建議有條件批準 Akcea 的 Waylivra(volanesorsen)用于家族乳糜微粒血癥綜合征(FCS)治療。FCS 是一種遺傳性疾病,該疾病會阻止身體分解脂肪,導致血液中甘油三酯水平升高。去年 Waylivra 曾被 FDA 拒絕,這次歐盟的支持對該公司來說是一種鼓勵。

              與此同時,BioMarin 的 Palynziq(pegvaliase)也獲得 CHMP 積極評價,Palynziq 是一種新的酶替代療法,其用于 16 歲及以上年齡的苯丙酮尿癥患者,苯丙酮尿癥是一種罕見但潛在嚴重的遺傳性代謝性疾病。這是 BioMarin 自主研發的 Kuvan(sapropterin)的首個替代產品,Kuvan 是目前歐盟獲批的唯一用于苯丙酮尿癥的藥品。

              賽諾菲還有另一款藥物獲得 CHMP 積極評價,該公司與 Lexicon 制藥公司合作的 SGLT1/2 抑制劑 Zynquista(sotagliflozin)作為口服藥物被推薦用于胰島素輔助治療,用以改善 1 型糖尿病患者的血糖控制。Zynquista 是繼一個月前阿斯利康達格列凈之后,第二款獲得批準的作用于 SGLT 的藥物。EvaluatePharma 表示,到 2022 年 Zynquista 的銷售額有望接近于 12 億美元。

              CHMP 還對其他藥物給出積極評價:

              ——推薦葛蘭素史克 Dectova(扎那米韋)在特殊情況下用于治療復雜的、潛在威及生命的流感;

              ——輝瑞的 Lorviqua(lorlatinib)被推薦用于 ALK 陽性晚期非小細胞肺癌治療;

              ——艾伯維和勃林格殷格翰的 IL-23 抑制劑 Skyrizi(risankizumab)被推薦用于中重度銀屑病治療。

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