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研究性ABBV-RGX-314作为NAMD的基因治疗：
1。luxturna [包装插入]。宾夕法尼亚州费城：Spark Therapeutics，Inc。修订了2022年4月。2024年8月22日访问。2。Maclaren RE等。hum gene ther。2024; 35（15-16）：564-575。3。yiu G等。mol ther方法clin dev。2020; 16：179-191。4。Campochiaro，PA等。《柳叶刀》，第403卷，第10436页，1563 - 1573年。NAMD：新血管相关的黄斑变性； AAV：腺相关病毒：IRD：遗传性视网膜疾病
ABBV-383（一种 B 细胞成熟抗原 × CD3 双特异性 T 细胞重定向抗体）在复发/难治性多发性骨髓瘤患者中的 I 期首次人体研究
结果截至 2022 年 1 月 8 日，124 名患者（剂量递增 [0.025-120 mg]，n 5 73；剂量扩大 [60 mg]，n 5 51）接受了 ABBV-383；中位年龄为 68 岁（范围，35-92 岁）。最常见的血液学治疗引起的不良事件 (TEAE) 是中性粒细胞减少症（所有等级：37%）和贫血（29%）。最常见的非血液学 TEAE 是细胞因子释放综合征（57%）和疲劳（30%）。报告了 7 例 TEAE 死亡病例，研究人员认为所有病例都与研究药物无关。对于所有可评估疗效的患者（n = 122；所有剂量），客观缓解率 (ORR) 为 57%，非常好的部分缓解 (VGPR) 或更好 ($VGPR) 率为 43%。在 60 mg 剂量扩展队列 (n = 49) 中，ORR 和 $VGPR 率分别为 59% 和 39%；在 $40 mg 剂量递增加剂量扩展队列 (n = 79) 中分别为 68% 和 54%。
Case M.9461 - ABBVIE / ALLERGAN - European Commission
(7) The ATC system is a hierarchical and coded four-level system, which classifies medicinal products by class according to their indication, therapeutic use, composition, and mode of action (“MoA”). In the first and broadest level (ATC 1), medicinal products are divided into the 16 anatomical main groups. The second level (ATC 2) is either a pharmacological or therapeutic group. The third level (ATC 3) further groups medicinal products by their specific therapeutic indications. Finally, 3 Turnover calculated in accordance with Article 5(1) of the Merger Regulation and the Commission Consolidated Jurisdictional Notice (OJ C95, 16.4.2008, p. 1). 4 FDPs refer to the finished dosage form of pharmaceutical products, which, in other words, are ready to be used by customers. FDPs contain (i) an active pharmaceutical ingredient (or “API”, which correspond to the component present within the product that provides the pharmacological action in the body, e.g. acetyl salicylic acid in an aspirin tablet), or a combination of APIs and (ii) other excipients. 5 See, for example, cases M.8974 – Procter & Gamble / Merck Consumer Health Business, decision of 27.8.2018; M.7919 – Sanofi/Boehringer Ingelheim Consumer healthcare Business, decision of 4.8.2016; M.6969 – Valeant Pharmaceuticals International/Bausch & Lomb Holdings, decision of 5.8.2013; M.5778 – Novartis/Alcon, decision of 9.8.2010; M.7276 – GlaxoSmithKline/ Novartis Vaccines Business (Excl. Influenza) / Novartis Consumer Health Business, decision of 28.1.2015; M.5865 – Teva / Ratiopharm, decision of 3.8.2010; and M.8889 – Teva / PGT OTC , decision of 29.1.2010.