Merck Announces Historic Agreement with U.S. Government to Expand Drug Access and Introduce First Oral PCSK9 Inhibitor
核心洞察
Merck (搜索) reached a historic agreement with the Trump administration to provide prescription medicines at lower costs through a direct-to-patient program, offering 70% discounts on diabetes (搜索) medications JANUVIA, JANUMET, and JANUMET XR (搜索).
The company plans to introduce enlicitide decanoate, a novel oral PCSK9 inhibitor designed to deliver antibody-like efficacy in a daily pill format, addressing the underutilization of existing injectable PCSK9 inhibitors.
Merck (搜索) committed over $70 billion in U.S. investments for manufacturing and R&D over the next several years, building on $12 billion in manufacturing investments since 2017 and $81 billion in R&D spending since 2018.
Merck (搜索) announced a historic agreement with the Trump administration on December 19, 2025, to ensure prescription medicines are both accessible and affordable for Americans through a comprehensive direct-to-patient program and the introduction of a groundbreaking oral PCSK9 inhibitor.
Direct-to-Patient Program Launches with Significant Price Reductions
The pharmaceutical giant will provide key diabetes (搜索) medications through a direct-to-patient program at substantially reduced prices for eligible patients. JANUVIA (sitagliptin), JANUMET (sitagliptin and metformin HCl), and JANUMET XR (搜索) (sitagliptin and metformin HCI extended-release) will be available to eligible American patients at approximately 70% off the current list price.
"As an American company, Merck (搜索) is proud to work with the Trump administration to further secure our country's position as a world leader in biopharmaceutical innovation," said Robert M. Davis, chairman and chief executive officer of Merck. "Today's agreement marks a pivotal step in ensuring Americans can access medicines they need at lower costs."
Novel Oral PCSK9 Inhibitor Addresses Cardiovascular Crisis
The agreement will expand to include enlicitide decanoate following FDA approval, representing a potential breakthrough in cardiovascular treatment. Enlicitide, designed to lower LDL cholesterol (搜索), was engineered to deliver PCSK9 antibody-like efficacy in an easy-to-use daily pill format, addressing a critical gap in current treatment options.
The cardiovascular epidemic represents the leading cause of deaths in America, with heart attacks and stroke contributing to most cardiovascular deaths. According to the company, one person dies every 36 seconds from cardiovascular disease (搜索). Despite the effectiveness of existing injectable PCSK9 inhibitors, they remain widely underused, creating an urgent need for more accessible treatment options.
"If approved, we intend to make enlicitide broadly available as an affordable option for American patients to help address the CV epidemic," the company stated. Enlicitide has the potential to become the first approved oral PCSK9 inhibitor, designed specifically to meet critical unmet needs for patients.
Addressing Global Pricing Disparities
The agreement directly tackles pricing imbalances between the U.S. and other nations, ensuring American patients no longer shoulder a disproportionate share of innovation costs. Merck (搜索) is voluntarily addressing all four components of the president's July letter, implementing steps to provide Americans with lower prices and broader access to prescription medicines.
"For too long, global pricing imbalances have shifted the financial burden of groundbreaking research and development onto the U.S. health care system and ultimately, American patients," Davis explained. "Merck (搜索) remains committed to expanding access and improving affordability across the system."
Massive U.S. Investment Commitment
Merck (搜索) has accelerated its commitment to U.S. innovation and manufacturing, building on its existing infrastructure of 15 manufacturing and R&D facilities and a workforce exceeding 30,000 Americans. The company has invested over $12 billion in U.S. manufacturing since 2017 and $81 billion in U.S.-based R&D since 2018, supporting tens of thousands of American jobs.
Over the next several years, Merck (搜索) will invest more than $70 billion in capital and R&D spending, including at least $12 billion in capital expenditures, to drive long-term growth and strengthen the U.S. position as a global leader in biopharmaceutical innovation. This includes recent announcements of manufacturing facilities in Virginia, Kansas, and Delaware, which will create 1,200 full-time jobs and support 15,000 construction jobs.
Manufacturing and Trade Considerations
The company reached an understanding with the U.S. Department of Commerce to delay Section 232 tariffs for three years, enabling investments in the United States to reshore manufacturing for American patients. This arrangement supports Merck (搜索)'s broader strategy to strengthen domestic pharmaceutical production capabilities while maintaining competitive pricing for patients.