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FDA Approves Aurinia Pharma's Lupkynis - Second Lupus Nephritis Drug In A Month

fdaaprovedim sep19 23jan21 lt

The FDA has approved Aurinia Pharmaceuticals Inc.'s (AUPH) LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis.

LUPKYNIS, generically known as voclosporin, becomes the second FDA-approved therapy for lupus nephritis, with the first being GlaxoSmithKline plc's (GSK) BENLYSTA, which was approved as recently as last month.

Aurinia's LUPKYNIS is administered orally while BENLYSTA is administered intravenously (IV) or subcutaneously.

The global peak sales of LUPKYNIS are estimated to be in excess of $1 billion, according to the company.

Lupus nephritis is an inflammation of the kidney caused by Systemic Lupus Erythematosus - resulting in irreversible kidney damage and increasing the risk of kidney failure, cardiac events, and death. It is estimated that lupus nephritis affects about 200,000 people in the U.S.

AUPH closed Friday's trading at $14.86, down 2.17%.

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