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Aurinia receives positive CHMP opinion for Lupkynis

Therapy effectively treats adults with active lupus nephritis in Europe.

Aurinia has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Lupkynis – also known as voclosporin.

It involves the treatment of adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The US Food and Drug Administration (FDA) approved it in 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

The positive opinion from CHMP is based on the results of the pivotal phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated Lupkynis was safe and well tolerated in adults with LN for up to three years of treatment with no new safety signals and stable renal function.

In December 2020, Aurinia had entered into a collaboration and licensing agreement with Otsuka for the development and commercialisation of Lupkynis for the treatment of LN in the European Union and several other countries across the world.

Based on the CHMP recommendation, a decision by the European Commission (EC) is expected in approximately two months. If granted by the EC, the centralised marketing authorisation would be valid in all EU member states as well as in Iceland, Liechtenstein and Norway.

“This positive recommendation brings us one step closer to delivering voclosporin to LN patients across Europe and with a strong history of commercialization in rare kidney disease, Otsuka is an ideal partner to bring voclosporin to patients to this market,” explained Peter Greenleaf, president and chief executive officer at Aurinia.

“I am proud of the outstanding efforts of our Aurinia submission team to prepare the MAA filing to secure this positive opinion and the strong collaboration between Aurinia and Otsuka to advance efforts to reach patient communities globally with this promising, important medicine,” added Sue Evans, vice president, global regulatory affairs at Aurinia.