Author Archives: Marisa Wexler, MS

First Skin Lupus Patient Dosed in Phase 2/3 Trial of Litifilimab

The first participant has been dosed in a pivotal Phase 2/3 trial testing Biogen’s anti-inflammatory medication litifilimab (BIIB059) in people with cutaneous lupus erythematosus (CLE), the company announced. The study, called AMETHYST (NCT05531565), is recruiting adults with CLE, whose disease is active despite standard antimalarial treatment, at…

Telitacicept Reduces SLE Severity in Phase 3 Trial in China

Telitacicept, a B-cell-targeting therapy developed by RemeGen, outperformed a placebo at reducing the severity of systemic lupus erythematosus (SLE) in a Phase 3 clinical trial in China, the company announced. “We are delighted with the news of the preliminary results of the Phase III confirmatory study of our proprietary…

European Commission OKs Lupkynis for Active Lupus Nephritis

The European Commission has approved Lupkynis (voclosporin) to treat active lupus nephritis, a serious complication of systemic lupus erythematosus (SLE) that is characterized by kidney inflammation. The approval is valid in all European Union (EU) member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Lupkynis received a similar…

Lupus Research Alliance Awards $9M for 3 New Projects

The Lupus Research Alliance (LRA) has announced $9 million in grants — three awards each totaling $3 million — to fund new research projects that aim to better understand lupus and pave the way toward the development of better treatment strategies for the inflammatory autoimmune disease. The funding is…

Alpine, Evotec Expanding Production of ALPN-303, Potential Therapy

Alpine Immune Sciences and Evotec announced the expansion of an agreement to manufacture ALPN-303, an experimental anti-inflammatory therapy that Alpine is developing for systemic lupus erythematosus (SLE) and other diseases driven by immune B-cells. Under the initial 2020 agreement, Evotec’s subsidiary Just-Evotec Biologics used its continuous manufacturing…

FDA Approves Benlysta for Children With Active Lupus Nephritis

The U.S. Food and Drug Administration (FDA) has extended the use of Benlysta (belimumab), given on top of standard therapy, to treat children ages 5 to 17 with active lupus nephritis, a serious form of kidney inflammation caused by lupus. Benlysta is the first FDA-approved treatment for pediatric lupus…