EMPAVELI

批准信原文要点

This Prior Approval sNDA provides for updates to the indication to describe an additional benefit (to reduce the loss of kidney function), in the indicated population: for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria and the loss of kidney function, as well as a proposed modification to the approved Empaveli REMS.

批准信原文要点

This Prior Approval sNDA provides for the use of Empaveli (pegcetacoplan) for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria, and proposed modification to the approved Empaveli REMS.

批准信原文要点

This Prior Approval sNDA provides for revisions to the Prescribing Information to update Section 5.3 Infusion-Related Reactions and add Section 6.2 Postmarketing Experience to incorporate anaphylaxis and urticaria as adverse drug reactions.

批准信原文要点

Your proposed modified REMS, submitted on April 10, 2024, amended and appended to this letter, is approved.

批准信原文要点

We also refer to our letter dated November 13, 2023, notifying you, under Section 505(o)(4) of the FDCA… complement inhibitor products… risk of serious infections caused by encapsulated bacteria.

批准信原文要点

This Prior Approval sNDA provides for the optional use of the Empaveli Injector (single-use on-body injector).

批准信原文要点

This new drug application provides for the use of Empaveli (pegcetacoplan) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).