AUPH - Aurinia lupus nephritis drug recommended in Europe

• Canadian biotech Aurinia Pharmaceuticals ( NASDAQ: AUPH ) announced on Friday that an advisory committee of the European Medicines Agency (EMA) issued a positive opinion on its lupus nephritis drug Lupkynis recommending its marketing authorization in the region.
• The decision of the EMA’s Committee for Medicinal Products for Human Use will pave the way for the European Commission (EC) to approve the drug under the brand name voclosporin for adults with active lupus nephritis.
• A positive decision from the EC expected in about two months will permit the sales of the treatment in all EU member states as well as in Iceland, Liechtenstein, and Norway. Aurinia ( AUPH ) is trading ~5% higher in the pre-market, currently.
• In January, the FDA approved Lupkynis with a background immunosuppressive therapy regimen to treat adults with active LN.
• Aurinia ( AUPH ) has partnered with Otsuka Pharmaceutical Co., Ltd. to develop and commercialize  voclosporin in Europe.

For further details see: