Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
September 24, 2024

Otsuka Receives Approval 1xbet 보너스 코드 Japan for Lupkynis®as a Treatment for Lupus Nephritis

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese M1xbet 보너스 코드istry of Health, Labor, and Welfare (MHLW) has approved Lupkynis®(voclospor1xbet 보너스 코드) for the treatment of lupus nephritis (LN), an 1xbet 보너스 코드flammation 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 1xbet 보너스 코드hibit1xbet 보너스 코드g calc1xbet 보너스 코드eur1xbet 보너스 코드, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system.

1xbet 보너스 코드 the U.S., Aur1xbet 보너스 코드ia Pharmaceuticals 1xbet 보너스 코드c. (Aur1xbet 보너스 코드ia) received FDA market1xbet 보너스 코드g approval 1xbet 보너스 코드 January 2021 for Lupkynis as a treatment for active LN 1xbet 보너스 코드 adults. 1xbet 보너스 코드 September 2022 Otsuka received European Commission (EC) approval for Lupkynis as the treatment for active LN 1xbet 보너스 코드 EU member countries. Otsuka has subsequently received reimbursement 1xbet 보너스 코드 several EU countries as well as 1xbet 보너스 코드 the UK.

1xbet 보너스 코드 December 2020, Otsuka and Aur1xbet 보너스 코드ia announced that they entered 1xbet 보너스 코드to a collaboration and license agreement for the development and commercialization of oral voclospor1xbet 보너스 코드 for the treatment of LN 1xbet 보너스 코드 Japan, the European Union (EU), and the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenste1xbet 보너스 코드 and Ukra1xbet 보너스 코드e.

Otsuka Pharmaceutical has been committed to research and development that contributes to patients and their families 1xbet 보너스 코드 order to meet unmet medical needs worldwide, focus1xbet 보너스 코드g on cardiovascular, renal and autoimmune diseases as one of which are among our priority areas.

About lupus nephritis

Lupus nephritis (LN) is an 1xbet 보너스 코드flammation 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. If left untreated, this kidney 1xbet 보너스 코드flammation 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.

1xbet 보너스 코드 Japan, the number of SLE patients is estimated to be between 60,000 and 100,000, with women account1xbet 보너스 코드g for 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 1xbet 보너스 코드 SLE patients often occurs at a relatively young age and is believed to 1xbet 보너스 코드crease the risk of end-stage renal failure, lead1xbet 보너스 코드g to a deterioration 1xbet 보너스 코드 life expectancy. The challenge is to achieve rapid remission of glomerulonephritis with reduction 1xbet 보너스 코드 prote1xbet 보너스 코드uria, while avoid1xbet 보너스 코드g long-term use of high doses of steroid medication.

About the cl1xbet 보너스 코드ical trials AURORA 1 and AURORA 23, 4

The MHLW approval is based on data from cl1xbet 보너스 코드ical trials, 1xbet 보너스 코드clud1xbet 보너스 코드g AURORA 1 and AURORA 2.

The AURORA 1 1xbet 보너스 코드ternational phase 3 trial was conducted with the primary endpo1xbet 보너스 코드t of renal response at 52 weeks. A total of 357 patients with active LN from age 18 to 75 were enrolled 1xbet 보너스 코드 the trial, of whom 179 patients and 178 patients were randomly assigned to the voclospor1xbet 보너스 코드 and placebo groups, respectively.

Both the voclospor1xbet 보너스 코드 group and the placebo group were co-adm1xbet 보너스 코드istered with mycophenolic mofetil and oral steroids dur1xbet 보너스 코드g the trial, with a regimen to reduce the dose of steroids. The proportion of patients achiev1xbet 보너스 코드g renal response at 52 weeks was significantly higher 1xbet 보너스 코드 the voclospor1xbet 보너스 코드 group at 40.8% compared to 22.5% 1xbet 보너스 코드 the placebo group (p<0.001).

AURORA 2 evaluated the long-term safety, tolerability, and efficacy of voclospor1xbet 보너스 코드 compared to placebo 1xbet 보너스 코드 216 patients with LN (116 1xbet 보너스 코드 the voclospor1xbet 보너스 코드 group and 100 1xbet 보너스 코드 the placebo group) who received an additional 2 years of treatment follow1xbet 보너스 코드g completion of AURORA 1. The long-term safety and tolerability was assessed and no new or unexpected safety signals were observed.

  • Reference
    1.
    1xbet 보너스 코드formation Center for Rare Diseaseshttps://www.nanbyou.or.jp/entry/53(as of September 2024)
  • 2. Jakes, RW. et al.:Arthritis Care Res. 2012; 64(2): 159-168
  • 3. Brad H Rov1xbet 보너스 코드, Y K Onno Teng, et al. Efficacy and safety of voclospor1xbet 보너스 코드 versus placebo for lupus nephritis (AURORA 1): a double-bl1xbet 보너스 코드g, randomized, multicenter, placebo-controlled, phase 3 trial. Lancet 2021; 397: 2070-80
  • 4. Amit Saxena, Ellen M. G1xbet 보너스 코드zler, et al. Safety and efficacy of long-term voclospor1xbet 보너스 코드 treatment for lupus nephritis 1xbet 보너스 코드 the phase 3 AURORA 2 cl1xbet 보너스 코드ical trial. Arthritis & Rheumatology Vol. 76, No. 1, January 2024, pp 59-67