安进134亿美元购进！阿普斯特片上市申请拟纳入优先审评

The CDE official website shows in 2021 that Amgen’s marketing application for Apremilast Tablets is planned to be included in priority review for the treatment of psoriasis.阿普斯特(apremilast)是一款小分子磷酸二酯酶4(PDE-4)抑制剂，主要通过调节细胞内促炎因子与抗炎因子发挥作用。最早于2014年3月在美国获批上市，用于治疗成人活动性银屑病关节炎，之后又扩展适应症用于治疗中重度斑块型银屑病和贝赫切特综合征（Behcet）相关的口腔溃疡。

What Apremilast tablets do:

Celgene has developed apremilast (apremilast), a new orally available small molecule drug targeting PDE4.众周所知,脂多糖( LPS)能够刺激人类外周生成并释放许多细胞因子包括IFNγ、TNFα、IL-2、IL-12及IL-23和趋化因子包括CXCL9 ( monokine由 IFN-γ或MIG诱导)及CXCL10 ( IFN-γ诱导的10kDa蛋白或IP-10)的生成，apremilast能抑制单核细胞的这些功能。 Apremilast还抑制巨噬细胞炎性蛋白( MIP )-1、单核细胞诱导蛋白(MCP)-1、外周血单核细胞(PBMC)产生的粒细胞巨噬细胞菌落刺激因子(GM-CSF)和诱导多形核(PMN)细胞的反应的IL-8和LTB4等细胞因子的生成。

Clinical studies on apremilast include a small clinical observation and three phase II clinical trials and one phase III clinical trial. In this small-scale clinical study, 19 patients were enrolled, 17 of whom completed the trial. On the 29th day of treatment, the epidermal thickness decreased by an average of 20.5% compared with baseline. In responding cases, dermal and epidermal T cells decreased by 28.8% and 42.6%, respectively, and CD11c cells decreased by 18.5% and 40.2%, respectively. Fourteen of 19 (73.7%) patients demonstrated improvement in psoriasis area and severity (PASI) scores.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

Recommended hot articles: