FDA Approves Leqvio and Expands Alhemo Use in One Day

Published on LinkedIn via Spencer Knight

The FDA has granted two approvals within 24 hours. Novartis’s Leqvio (inclisiran), a twice-yearly siRNA targeting PCSK9, is now approved as monotherapy to lower LDL-C without statins. Novo Nordisk’s Alhemo (concizumab) received expanded approval to treat haemophilia A and B patients aged 12 and older without inhibitors. Alhemo, a first-in-class anti-TFPI monoclonal antibody, demonstrated bleeding reduction of 86 percent for haemophilia A and 79 percent for B. Both advances support easier, more convenient chronic disease management.

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👉 Two FDA approvals in one day: Leqvio and Alhemo

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