Merck Wins FDA Approval for First Oral PCSK9 Inhibitor Lipfendra
Merck announced FDA approval of Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor for lowering LDL cholesterol, bolstering its post-Keytruda pipeline with multi-billion-dollar sales potential.
The U.S. Food and Drug Administration has approved Merck's Lipfendra (enlicitide), a once-daily oral PCSK9 inhibitor designed to significantly reduce LDL cholesterol in adults. The drug is the first oral therapy in this class, offering an alternative to existing injectable PCSK9 treatments.
Analysts see the approval as a key step in Merck's strategy to sustain growth beyond its blockbuster cancer drug Keytruda, with expectations that Lipfendra could generate multi-billion-dollar annual sales as it competes for a share of the cholesterol-lowering market.
Source: First Squawk