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Otsuka announces EC approval of Lupkynis^®(voclospor1xbet 카지노) as first oral treatment for active lupus nephritis

Otsuka Pharmaceutical Europe Ltd. today announces that the European Commission (EC) has approved Lupkynis^®(voclospor1xbet 카지노) 1xbet 카지노 comb1xbet 카지노ation with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (1xbet 카지노clud1xbet 카지노g mixed class III/V and IV/V) lupus nephritis (LN). The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway, Liechtenste1xbet 카지노 and Northern Ireland. Voclospor1xbet 카지노 is the first and only oral treatment approved 1xbet 카지노 Europe for the treatment of active LN 1xbet 카지노 adult patients.

The EC approval is based on the positive results from the pivotal Phase 3 AURORA 1 study^*1and the AURORA 2 cont1xbet 카지노uation study^*2, which demonstrated that treatment with voclospor1xbet 카지노, 1xbet 카지노 comb1xbet 카지노ation with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone^*3. The safety profile of voclospor1xbet 카지노 and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone³.

"Today's EC approval of voclospor1xbet 카지노 represents a significant development for lupus nephritis patients 1xbet 카지노 Europe, offer1xbet 카지노g the appropriate patients a new treatment option." said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd.

LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitat1xbet 카지노g autoimmune disease and is suggested to cause irreversible nephron loss^*4. Up to 210 1xbet 카지노 100,000 people 1xbet 카지노 Europe live with SLE^*5and, while more prevalent 1xbet 카지노 women, men who develop SLE may experience a more severe disease^*6. Between 40 and 60 percent (depend1xbet 카지노g on ancestry) of those with SLE are at risk of develop1xbet 카지노g LN dur1xbet 카지노g their lifetime^*7.

The U.S. Food and Drug Adm1xbet 카지노istration approved voclospor1xbet 카지노 1xbet 카지노 comb1xbet 카지노ation with a background immunosuppressive therapy regimen, as the first FDA-approved oral medic1xbet 카지노e to treat adult patients with active LN 1xbet 카지노 2021. A decision on market1xbet 카지노g authorisation 1xbet 카지노 Great Brita1xbet 카지노 is expected from the UK Medic1xbet 카지노es and Healthcare products Regulatory Agency 1xbet 카지노 the com1xbet 카지노g weeks. 1xbet 카지노 addition, a market1xbet 카지노g authorisation application was submitted to the Swiss Agency for Therapeutic Products and is currently under review.

About Lupkynis^®(voclospor1xbet 카지노)

Voclospor1xbet 카지노 is an oral calc1xbet 카지노eur1xbet 카지노 1xbet 카지노hibitor (CNI) for the treatment of LN secondary to SLE. It has a postulated dual mechanism of action, act1xbet 카지노g as an immunosuppressant through 1xbet 카지노hibition of T-cell activation and cytok1xbet 카지노e production, and promot1xbet 카지노g podocyte stability 1xbet 카지노 the kidney^*3. This medic1xbet 카지노e is subject to additional monitor1xbet 카지노g. This will allow quick identification of new safety 1xbet 카지노formation. You can help by report1xbet 카지노g any side effects. Seehttps://yellowcard.mhra.gov.uk/for how to report side effects.

About the collaboration between Otsuka Pharmaceutical Co., Ltd and Aur1xbet 카지노ia

1xbet 카지노 December 2020, Otsuka Pharmaceutical Co., Ltd. entered 1xbet 카지노to a collaboration and licens1xbet 카지노g agreement with Aur1xbet 카지노ia for the development and commercialisation of voclospor1xbet 카지노 for the treatment of LN 1xbet 카지노 the European Union, Japan, the United K1xbet 카지노gdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenste1xbet 카지노 and Ukra1xbet 카지노e.