FDA approves IL | 合法藥品大搜索

2019年4月23日—Risankizumab,aninterleukin-23inhibitor,hasbeenapprovedbytheFoodandDrugAdministrationfortreatingmoderatetosevereplaque ...

Risankizumab, an interleukin-23 inhibitor, has been approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the manufacturer announced on April 23.

Risankizumab[1] selectively inhibits interleukin-23 (IL-23), a key inflammatory protein, by binding to its p19 subunit. The drug is administered at a dose of 150 mg, in two subcutaneous injections, every 12 weeks, after starting doses at weeks 0 and 4. It will be available in early May, according to an AbbVie press release announcing the approval.

The approval was based in part on data from two phase 3, 2-year studies, In UltIMMA-1[2] and UltIMMA-2[3], at 16 weeks, 75% of risankizumab patients in both studies achieved a Psoriasis Area and Severity Index (PASI 90), compared with 5% and 2% of those on placebo, respectively. These results were published in 2018 (Lancet. 2018 Aug 25;392[10148]:650-61[4]).

At 1 year, 82% ...