Merck LIPFENDRA (Enlicitide) Post-Approval Analyst Coverage: Financial Analysts Model More Than $2 Billion in Peak Annual Sales After First Few Years on the Market, RBC Capital Markets Calls the Label 'The Cleanest in the PCSK9 Class' With Zero Contraindications or Hypersensitivity Warnings (Unlike Approved Injectable Competitors Amgen Repatha, Regeneron/Sanofi Praluent, and Novartis Leqvio), and Merck Confirms the CORALreef Outcomes Cardiovascular Trial (NCT06008756) Has Completed Enrollment at More Than 14,500 Participants to Test the Cardiovascular Morbidity and Mortality Question
Analyst coverage of Merck's LIPFENDRA (enlicitide) FDA approval (Thursday July 16) crystallized Friday. Financial analysts projected LIPFENDRA can generate more than $2 billion in annual sales after a few years on the market. RBC Capital Markets described the label as 'the cleanest in the PCSK9 class,' noting zero contraindications or hypersensitivity warnings, unlike the currently approved injectable PCSK9 competitors (Amgen Repatha/evolocumab, Regeneron/Sanofi Praluent/alirocumab, and Novartis Leqvio/inclisiran). In supporting Phase 3 data, LIPFENDRA statistically outperformed other oral non-statin drugs (Nexletol/bempedoic acid and Zetia/ezetimibe) in adjunctive hypercholesterolemia populations. LIPFENDRA continues to be evaluated in the large cardiovascular outcomes trial CORALreef Outcomes (NCT06008756), which Merck confirmed has completed enrollment with more than 14,500 participants. It is not yet known whether LIPFENDRA reduces cardiovascular morbidity and mortality; the outcomes trial will address that question. Additional data on the safety profile: in CORALreef Lipids, adverse-reaction frequencies were similar between LIPFENDRA and placebo; in CORALreef HeFH the most common adverse reactions more frequent versus placebo were diarrhea (7% vs. 2%) and dizziness (9% vs. 4%), with discontinuation rates similar to placebo.