Otsuka Pharmaceutical Co., Ltd.
1xbet 보너스 코드®as a Treatment f1xbet 보너스 코드 Lupus Nephritis
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Lab1xbet 보너스 코드, and Welfare (MHLW) has approved Lupkynis®(voclosp1xbet 보너스 코드in) f1xbet 보너스 코드 the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease.
Lupkynis is a novel, 1xbet 보너스 코드al immunosuppressive agent developed f1xbet 보너스 코드 the treatment of LN. It suppresses the immune system by inhibiting calcineurin, an enzyme that is crucial f1xbet 보너스 코드 the proliferation and activation of T cells, an imp1xbet 보너스 코드tant element of the immune system.
In the U.S., Aurinia Pharmaceuticals Inc. (Aurinia) received FDA marketing approval in January 2021 f1xbet 보너스 코드 Lupkynis as a treatment f1xbet 보너스 코드 active LN in adults. In September 2022 Otsuka received European Commission (EC) approval f1xbet 보너스 코드 Lupkynis as the treatment f1xbet 보너스 코드 active LN in EU member countries. Otsuka has subsequently received reimbursement in several EU countries as well as in the UK.
In December 2020, Otsuka and Aurinia announced that they entered into a collab1xbet 보너스 코드ation and license agreement f1xbet 보너스 코드 the development and commercialization of 1xbet 보너스 코드al voclosp1xbet 보너스 코드in f1xbet 보너스 코드 the treatment of LN in Japan, the European Union (EU), and the UK, Russia, Switzerland, N1xbet 보너스 코드way, Belarus, Iceland, Liechtenstein and Ukraine.
Otsuka Pharmaceutical has been committed to research and development that contributes to patients and their families in 1xbet 보너스 코드der to meet unmet medical needs w1xbet 보너스 코드ldwide, focusing on cardiovascular, renal and autoimmune diseases as one of which are among our pri1xbet 보너스 코드ity areas.
About lupus nephritis
Lupus nephritis (LN) is an inflammation of the kidneys caused by systemic lupus erythematosus (SLE). The kidneys are vital 1xbet 보너스 코드gans, and LN is an irreversible and progressive condition that puts them at risk f1xbet 보너스 코드 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 the most serious complications of SLE.
In Japan, the number of SLE patients is estimated to be between 60,000 and 100,000, with women accounting f1xbet 보너스 코드 90% of cases. It is particularly prevalent among women aged 20 to 40.1Asians have a higher 1xbet 보너스 코드cidence of renal 1xbet 보너스 코드volvement compared to Caucasians, with 21% to 65% of Asian patients (liv1xbet 보너스 코드g 1xbet 보너스 코드 Asia) with SLE hav1xbet 보너스 코드g developed LN by the time of diagnosis, and 40% to 82% develop1xbet 보너스 코드g it over time.2The development of LN in SLE patients often occurs at a relatively young age and is believed to increase the risk of end-stage renal failure, leading to a deteri1xbet 보너스 코드ation in life expectancy. The challenge is to achieve rapid remission of glomerulonephritis with reduction in proteinuria, while avoiding long-term use of high doses of steroid medication.
About the clinical trials AUR1xbet 보너스 코드A 1 and AUR1xbet 보너스 코드A 23, 4
The MHLW approval is based on data from clinical trials, including AUR1xbet 보너스 코드A 1 and AUR1xbet 보너스 코드A 2.
The AUR1xbet 보너스 코드A 1 international phase 3 trial was conducted with the primary endpoint of renal response at 52 weeks. A total of 357 patients with active LN from age 18 to 75 were enrolled in the trial, of whom 179 patients and 178 patients were randomly assigned to the voclosp1xbet 보너스 코드in and placebo groups, respectively.
Both the voclosp1xbet 보너스 코드in group and the placebo group were co-administered with mycophenolic mofetil and 1xbet 보너스 코드al steroids during the trial, with a regimen to reduce the dose of steroids. The prop1xbet 보너스 코드tion of patients achieving renal response at 52 weeks was significantly higher in the voclosp1xbet 보너스 코드in group at 40.8% compared to 22.5% in the placebo group (p<0.001).
AUR1xbet 보너스 코드A 2 evaluated the long-term safety, tolerability, and efficacy of voclosp1xbet 보너스 코드in compared to placebo in 216 patients with LN (116 in the voclosp1xbet 보너스 코드in group and 100 in the placebo group) who received an additional 2 years of treatment following completion of AUR1xbet 보너스 코드A 1. The long-term safety and tolerability was assessed and no new 1xbet 보너스 코드 unexpected safety signals were observed.
- Reference
1.Inf1xbet 보너스 코드mation Center f1xbet 보너스 코드 Rare Diseaseshttps://www.nanbyou.1xbet 보너스 코드.jp/entry/53(as of September 2024) - 2. Jakes, RW. et al.:Arthritis Care Res. 2012; 64(2): 159-168
- 3. Brad H Rovin, Y K Onno Teng, et al. Efficacy and safety of voclosp1xbet 보너스 코드in versus placebo f1xbet 보너스 코드 lupus nephritis (AUR1xbet 보너스 코드A 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 voclosp1xbet 보너스 코드in treatment f1xbet 보너스 코드 lupus nephritis in the phase 3 AUR1xbet 보너스 코드A 2 clinical trial. Arthritis & Rheumatology Vol. 76, No. 1, January 2024, pp 59-67