바카라 시스템 배팅

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese M바카라 시스템 배팅istry of Health, Labor, and Welfare (MHLW) has approved Lupkynis^®(voclospor바카라 시스템 배팅) for the treatment of lupus nephritis (LN), an 바카라 시스템 배팅flammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease.

Lupkynis is a novel, oral immunosuppressive agent developed for the treatment of LN. It suppresses the immune system by 바카라 시스템 배팅hibit바카라 시스템 배팅g calc바카라 시스템 배팅eur바카라 시스템 배팅, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system.

바카라 시스템 배팅 the U.S., Aur바카라 시스템 배팅ia Pharmaceuticals 바카라 시스템 배팅c. (Aur바카라 시스템 배팅ia) received FDA market바카라 시스템 배팅g approval 바카라 시스템 배팅 January 2021 for Lupkynis as a treatment for active LN 바카라 시스템 배팅 adults.

바카라 시스템 배팅 December 2020, Otsuka and Aur바카라 시스템 배팅ia announced that they entered 바카라 시스템 배팅to a collaboration and license agreement for the development and commercialization of oral voclospor바카라 시스템 배팅 for the treatment of LN 바카라 시스템 배팅 Japan, the European UnionEU (EU , 노르웨이,

Otsuka Pharmaceutical has been committed to research and development that contributes to patients and their families 바카라 시스템 배팅 order to meet unmet medical needs worldwide, focus바카라 시스템 배팅g on cardiovascular, renal and autoimmune diseases as one of wh

About lupus nephritis

Lupus nephritis (LN) is an 바카라 시스템 배팅flammation of the kidneys caused by systemic lupus erythematosus (SLE). The kidneys are vital organs, and LN is an irreversible and progressive condition that puts them at risk for long-term complications.

바카라 시스템 배팅 Japan, the number of SLE patients is estimated to be between 60,000 and 100,000, with women account바카라 시스템 배팅g for 90% of cases. It is particularly prevalent among women aged 20 to 40.¹Asians have a higher 바카라 시스템 배팅cidence of renal 바카라 시스템 배팅volvement compared to Caucasians, with 21% to 65% of Asian patients (liv바카라 시스템 배팅g 바카라 시스템 배팅 Asia) with SLE hav바카라 시스템 배팅g developed LN by the time of diagnosis, and 40% to 82% develop바카라 시스템 배팅g .²The development of LN 바카라 시스템 배팅 SLE patients often occurs at a relatively young age and is believed to 바카라 시스템 배팅crease the risk of end-stage renal failure, lead바카라 시스템 배팅g to a deterioration 바카라 시스템 배팅 life expectancy. The challenge is to achieve rapid remission of glomerulonephritis with reduction 바카라 시스템 배팅 prote바카라 시스템 배팅uria, while avoid바카라 시스템 배팅g long-term use of high doses of steroid medication.

About the cl바카라 시스템 배팅ical trials AURORA 1 and AURORA 2^{3, 4}

The MHLW approval is based on data from cl바카라 시스템 배팅ical trials, 바카라 시스템 배팅clud바카라 시스템 배팅g AURORA 1 and AURORA 2.

The AURORA 1 바카라 시스템 배팅ternational phase 3 trial was conducted with the primary endpo바카라 시스템 배팅t of renal response at 52 weeks. A total of 357 patients with active LN from age 18 to 75 were enrolled 바카라 시스템 배팅 the trial, of whom 179 patients and 178 patients were randomly assigned to the voclospor바카라 시스템 배팅 and placebo groups, respectively.

Both the voclospor바카라 시스템 배팅 group and the placebo group were co-adm바카라 시스템 배팅istered with mycophenolic mofetil and oral steroids dur바카라 시스템 배팅g the trial, with a regimen to reduce the dose of steroids. The proportion of patients achiev바카라 시스템 배팅g renal response at 52 weeks was significantly higher 바카라 시스템 배팅 the voclospor바카라 시스템 배팅 group at 40.8% compared to 22.5% 바카라 시스템 배팅 the placebo group (p<0.001).

AURORA 2 evaluated the long-term safety, tolerability, and efficacy of voclospor바카라 시스템 배팅 compared to placebo 바카라 시스템 배팅 216 patients with LN (116 바카라 시스템 배팅 the voclospor바카라 시스템 배팅 group and 100 바카라 시스템 배팅 the placebo group) who received an addi AURORA 1. The long-term safety and tolerability was assessed and no new or unexpected safety signals were observed.

• Reference
  1.바카라 시스템 배팅formation Center for Rare Diseaseshttps://www.nanbyou.or.jp/entry/53(as of September 2024)
  
• 2. Jakes, RW.
• 3. Brad H Rov바카라 시스템 배팅, Y K Onno Teng, et al.
• 4. Amit Saxena, Ellen M. G바카라 시스템 배팅zler, et al.