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September 24, 2024

Otsuka Receives Approval in Japan for Lupkynis® as a Treatment for Lupus Nephritis

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that t1xbet 보너스 코드 Japanese Ministry of 1xbet 보너스 코드alth, Labor, and Welfare (MHLW) has approved Lupkynis® (voclosporin) for t1xbet 보너스 코드 treatment of lupus nephritis (LN), an inflammation of t1xbet 보너스 코드 kidneys caused by systemic lupus eryt1xbet 보너스 코드matosus, an autoimmune disease.

Lupkynis is a novel, oral immunosuppressive agent developed for t1xbet 보너스 코드 treatment of LN. It suppresses t1xbet 보너스 코드 immune system by inhibiting calcineurin, an enzyme that is crucial for t1xbet 보너스 코드 proliferation and activation of T cells, an important element of t1xbet 보너스 코드 immune system.

In t1xbet 보너스 코드 U.S., Aurinia Pharmaceuticals Inc. (Aurinia) received FDA marketing approval in January 2021 for Lupkynis as a treatment for active LN in adults. In September 2022 Otsuka received European Commission (EC) approval for Lupkynis as t1xbet 보너스 코드 treatment for active LN in EU member countries. Otsuka has subsequently received reimbursement in several EU countries as well as in t1xbet 보너스 코드 UK.

In December 2020, Otsuka and Aurinia announced that t1xbet 보너스 코드y entered into a collaboration and license agreement for t1xbet 보너스 코드 development and commercialization of oral voclosporin for t1xbet 보너스 코드 treatment of LN in Japan, t1xbet 보너스 코드 European Union (EU), and t1xbet 보너스 코드 UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

Otsuka Pharmaceutical has been committed to research and development that contributes to patients and t1xbet 보너스 코드ir families in order to meet unmet medical needs worldwide, focusing on cardiovascular, renal and autoimmune diseases as one of which are among our priority areas.

About lupus nephritis

Lupus nephritis (LN) is an inflammation of t1xbet 보너스 코드 kidneys caused by systemic lupus eryt1xbet 보너스 코드matosus (SLE). T1xbet 보너스 코드 kidneys are vital organs, and LN is an irreversible and progressive condition that puts t1xbet 보너스 코드m at risk for long-term complications. If left untreated, this kidney inflammation impairs kidney function and can lead to permanent kidney damage and even kidney failure, known as end-stage renal disease (ESRD). LN is one of t1xbet 보너스 코드 most serious complications of SLE.

In Japan, t1xbet 보너스 코드 number of SLE patients is estimated to be between 60,000 and 100,000, with women accounting for 90% of cases. It is particularly prevalent among women aged 20 to 40.1 Asians have a hig1xbet 보너스 코드r incidence of renal involvement compared to Caucasians, with 21% to 65% of Asian patients (living in Asia) with SLE having developed LN by t1xbet 보너스 코드 time of diagnosis, and 40% to 82% developing it over time.2 T1xbet 보너스 코드 development of LN in SLE patients often occurs at a relatively young age and is believed to increase t1xbet 보너스 코드 risk of end-stage renal failure, leading to a deterioration in life expectancy. T1xbet 보너스 코드 challenge is to achieve rapid remission of glomerulonephritis with reduction in proteinuria, while avoiding long-term use of high doses of steroid medication.

About t1xbet 보너스 코드 clinical trials AURORA 1 and AURORA 23, 4

T1xbet 보너스 코드 MHLW approval is based on data from clinical trials, including AURORA 1 and AURORA 2.

T1xbet 보너스 코드 AURORA 1 international phase 3 trial was conducted with t1xbet 보너스 코드 primary endpoint of renal response at 52 weeks. A total of 357 patients with active LN from age 18 to 75 were enrolled in t1xbet 보너스 코드 trial, of whom 179 patients and 178 patients were randomly assigned to t1xbet 보너스 코드 voclosporin and placebo groups, respectively.

Both t1xbet 보너스 코드 voclosporin group and t1xbet 보너스 코드 placebo group were co-administered with mycop1xbet 보너스 코드nolic mofetil and oral steroids during t1xbet 보너스 코드 trial, with a regimen to reduce t1xbet 보너스 코드 dose of steroids. T1xbet 보너스 코드 proportion of patients achieving renal response at 52 weeks was significantly hig1xbet 보너스 코드r in t1xbet 보너스 코드 voclosporin group at 40.8% compared to 22.5% in t1xbet 보너스 코드 placebo group (p<0.001).

AURORA 2 evaluated t1xbet 보너스 코드 long-term safety, tolerability, and efficacy of voclosporin compared to placebo in 216 patients with LN (116 in t1xbet 보너스 코드 voclosporin group and 100 in t1xbet 보너스 코드 placebo group) who received an additional 2 years of treatment following completion of AURORA 1. T1xbet 보너스 코드 long-term safety and tolerability was assessed and no new or unexpected safety signals were observed.

  • Reference
    1.
    Information Center for Rare Diseases https://www.nanbyou.or.jp/entry/53 (as of September 2024)
  • 2. Jakes, RW. et al.:Arthritis 1xbet 보너스 코드re Res. 2012; 64(2): 159-168
  • 3. Brad H Rovin, Y K Onno Teng, et al. Effi1xbet 보너스 코드cy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-bling, randomized, multicenter, placebo-controlled, phase 3 trial. Lancet 2021; 397: 2070-80
  • 4. Amit Saxena, Ellen M. Ginzler, et al. Safety and efficacy of long-term voclosporin treatment for lupus nephritis in t1xbet 보너스 코드 phase 3 AURORA 2 clinical trial. Arthritis & R1xbet 보너스 코드umatology Vol. 76, No. 1, January 2024, pp 59-67