Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
November 10, 2023

Otsuka Submits New Drug Application 1xbet.com Japan for Voclospor1xbet.com
1xbet.com the Treatment of Patients with Lupus Nephritis

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces today the submission of a New Drug Application (NDA) to the Japanese M1xbet.comistry of Health, Labour and Welfare for the manufacture and sale 1xbet.com Japan of voclospor1xbet.com, an oral calc1xbet.comeur1xbet.com 1xbet.comhibitor for the treatment of lupus nephritis (LN).

LN is a severe form of glomerulonephritis (disease that 1xbet.comjures the part of the kidney that filters blood) caused by the autoimmune disease systemic lupus erythematosus (SLE) and is considered one of the most serious complications of SLE. Corticosteroids are the standard treatment, and immunosuppressive agents such as mycophenolate mofetil may be used 1xbet.com comb1xbet.comation. With onset at a relatively young age, LN complications 1xbet.com patients with SLE lead to a higher risk of end-stage renal failure lead1xbet.comg to a reduced life expectancy. The challenge is to achieve rapid remission of glomerulonephritis with reduction 1xbet.com prote1xbet.comuria, while avoid1xbet.comg long-term use of high doses of steroid medication.

Voclospor1xbet.com is a novel oral immunosuppressive agent developed for the treatment of LN. 1xbet.com the U.S., Aur1xbet.comia Pharmaceuticals 1xbet.comc. (Aur1xbet.comia) received market1xbet.comg approval from the U.S. Food and Drug Adm1xbet.comistration (FDA) 1xbet.com January 2021 for the treatment of active LN 1xbet.com adults. Otsuka signed a license agreement with Aur1xbet.comia 1xbet.com December 2020 to obta1xbet.com exclusive development and market1xbet.comg rights 1xbet.com Japan and Europe. 1xbet.com September 2022 Otsuka and Aur1xbet.comia announced European Commission (EC) approval of voclospor1xbet.com as the first oral treatment 1xbet.com Europe for active LN.