Sibeprenlimab (Voyxact – Otsuka), a subcutaneously injected cytokine A proliferation-inducing ligand (APRIL) blocker, has been granted accelerated approval by the FDA to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk for disease progression. Sibeprenlimab is the first APRIL blocker to be approved in the US. Atacicept (Trutakna), a B-lymphocyte stimulator and APRIL blocker, was recently granted accelerated FDA approval for the same indication; it will be reviewed in a future issue.

The FDA has removed the Risk Evaluation and Mitigation Strategy (REMS) requirement for the endothelin receptor antagonists ambrisentan (Letairis, and generics), bosentan (Tracleer, and generics), macitentan (Opsumit, and generics; Opsynvi), and aprocitentan (Tryvio), and the endothelin receptor antagonist and angiotensin II receptor antagonist sparsentan (Filspari) that was initially implemented because of a possible risk of embryofetal toxicity.