U.S. FDA approves new cholesterol-lowering pill, Merck shares near record high
US pharmaceutical company Merck announced on Thursday that its new oral cholesterol-lowering drug has been approved by the US FDA. Affected by this, the company's stock price rose by more than 3% during the session, approaching a record high. (Daily Chart of Merck, Source: TradingView) It is reported that this drug called Lipfendra works by inhibiting a protein called PCSK9. Clinical trial data shows that the daily oral drug can reduce levels of low-density lipoprotein (LDL), the "bad cholesterol," to 50 to 60 mg/dL.
US pharmaceutical company Merck announced on Thursday that its new oral cholesterol-lowering drug has been approved by the US FDA. Affected by this, the company's stock price rose by more than 3% during the session, approaching a record high. (Daily chart of MSD, source: TradingView) It is reported that this drug called Lipfendra works by inhibiting a protein called PCSK9. Clinical trial data shows that the daily oral drug can reduce levels of low-density lipoprotein (LDL), the "bad cholesterol," to 50 to 60 mg/dL. (Source: Company official website) For reference, adults who are not taking cholesterol-lowering drugs tend to have LDL levels around 100 mg/dL or higher. The latest cholesterol guidelines from the American Heart Association and the American College of Cardiology state that people with a higher-than-average risk of heart attack or stroke should keep their LDL levels below 70; people at higher risk, such as those who have had a heart attack, should keep their LDL levels below 55. Clinical trials have shown that the effect of Lipfendra is similar to that of injectable PCSK9 drugs, and is significantly better than Zetia (ezetimibe), Esperion's Nexletol (bepedic acid), and the combination of the two drugs launched earlier by Merck. A direct comparison test showed that when statins were used at the same time, the LDL level of patients taking Lipfendra dropped by approximately 64.6% from baseline after 8 weeks, which was 56.7 percentage points lower than that of bepedic acid, 36.0 percentage points lower than that of ezetimibe, and 28.1 percentage points lower than that of bepedic acid + ezetimibe combination. As the first oral PCSK9 inhibitor approved in the United States, the core competitiveness of this drug is naturally that it does not require injections. It is also priced at nearly half the price of similar products. Dr. Dean Lee, president of Merck Research Laboratories, said the company hopes to make Lipfendra lowering cholesterol as easy and convenient for patients as taking a statin. The drug can be prescribed by primary care physicians and does not need to be restricted to cardiologists. He also said patients are often used to taking daily medication. Most people who are at higher risk for a heart attack tend to already take at least one blood pressure medication, statin, and aspirin. In studies of the injectable drug, blocking PCSK9 reduced the incidence of heart attacks, strokes and cardiovascular death by 20% in high-risk groups. Merck is currently conducting a study to verify whether Lipfendra has the same effect. Wall Street analysts predict that the drug's peak annual revenue could reach $4.2 billion. "We believe this approval will add a multi-billion-dollar blockbuster product to Merck's portfolio, and the oral version is expected to significantly expand the PCSK9 drug market," JPMorgan analyst Chris Short said in a note to investors. Short added that the approval came three months earlier than expected. Even considering that Merck submitted its application through the Priority Review Voucher program launched last year to speed up reviews, this progress is still faster than expected. Merck spokesperson Julia Cunningham said Lipfendra will be priced at $315 for a 30-day supply and will be available within weeks. In horizontal comparison, injectable drugs with the same mechanism are usually priced as high as US$500 to US$600 per month. (