FDA Approves a First-of-Its-Kind Pill to Cut Cholesterol in High-Risk Patients
The once-daily tablet lowered LDL cholesterol by up to 60% in trials and could widen access to a therapy long limited to injections.
- On Thursday, the Food and Drug Administration approved Merck's Lipfendra, the first oral PCSK9 inhibitor for treating high cholesterol, bolstering the company's efforts to diversify beyond its blockbuster cancer treatment Keytruda.
- The cholesterol market is currently dominated by expensive injectable PCSK9-inhibitor drugs like Amgen's Repatha and Sanofi's Praluent, yet only 1% of 6 million eligible patients use these injectables, which cost up to $600 monthly.
- With a list price of $315 for a 30-day supply, Lipfendra lowers LDL cholesterol levels by up to 60% by blocking the PCSK9 protein, offering a more convenient alternative to injections.
- Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston, said the approval is "thrilling," while Merck Research Laboratories president Dr. Dean Li noted the drug is easy for primary care doctors to prescribe.
- Scotiabank analyst Louise Chen projects "peak sales potential of tens of billions of dollars," as Merck studies if Lipfendra reduces heart attack risks while Keytruda patent protections expire in 2028.
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The First Oral Cholesterol Pill Is Here. Which of These 5 Stocks Benefits Most?
The FDA just approved the first once-daily oral PCSK9 pill, and five major stocks now sit in the crosshairs. Not all of them come out ahead, and the biggest surprise winner may not be the company that makes the drug.
New pills can lower cholesterol levels much more than can be achieved with statins, as demonstrated by clinical trials.
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