Sacituzumab tirumotecan

The latest batch of accords brings the total number of most-favored-nation deals that the Trump administration has signed with major pharma companies to 14. Nine large pharma companies have reached agreements with the Trump administration to lower certain drug prices in the U.S.Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, GSK, Merck & Co., Novartis, Roche’s Genentech and Sanofi have agreed with the White House to reduce the prices of certain prescription medicines in exchange for pharmaceutical tariff relief, President Donald Trump announced at an event Friday together with top U.S. health officials and senior executives from the companies.The latest batch of accords follows other similar “most favored nation” deals struck by Pfizer, AstraZeneca, Merck KGaA’s EMD Serono, Eli Lilly and Novo Nordisk in recent months.Trump sent letters to the leaders of 17 large pharma companies back in July demanding them to match U.S. prices of their new drugs with the lowest prices offered in other developed nations, which underscores the concept of the most-favored-nation (MFN) pricing.AbbVie, Johnson & Johnson and Regeneron are the remaining drugmakers on Trump’s list. Deals with those companies may not be too far away; Trump said these three firms, specifically highlighting J&J, will come to the White House next week, but he was then reminded it will happen after the holiday. J&J has been talking with the Trump administration “since day 1, even before day 1,” J&J CEO Joaquin Duato said on the company’s third-quarter earnings call in October. The company is looking to find “common ground” with the administration on shared priorities, the CEO added. The exact terms of the deals so far have mostly remained confidential. According to Trump, the companies will offer some of their medicines in the U.S. at the lowest prices in the developed world.For Amgen, the California company said it will expand its direct-to-patient program, AmgenNow, to include migraine prevention drug Aimovig and Humira biosimilar Amjevita at 60% and 80% discounts from their current U.S.list prices, respectively.BMS said it will soon provide its Pfizer-partnered anticoagulant Eliquis for free to Medicaid and that it will “donate more than seven tons of Eliquis active pharmaceutical ingredient (API) to ensure American supply chain resilience.” As an old drug, Eliquis is slated to face a major Medicare price reduction as part of the Inflation Reduction Act. Gilead is offering discounts on certain existing medicines for HIV, hepatitis and COVID-19 through Medicaid to bring them on par with other developed countries, the company said. The firm will offer its hepatitis C drug Epclusa at a 90% discount through TrumpRx.gov, a new direct-to-consumer drug purchasing platform operated by the federal government, according to a White House fact sheet. Merck plans to provide three of its diabetes products—Januvia, Janumet and Janumet XR—through a direct-to-patient program “at affordable prices,” according to the company's press release. The New Jersey pharma said it plans to include its experimental oral PCSK9 drug enlicitide in the future following a potential FDA approval. In what appears to be part of the MFN deal, the FDA has granted Merck a Commissioner’s National Priority Voucher (CNPV) for enlicitide for lowering LDL cholesterol. Another Merck candidate, TROP2-directed antibody-drug candidate sacituzumab tirumotecan (sac-TMT), also received a CNPV that will significantly reduce the FDA’s review time of the cancer treatment in the future.Sanofi said it will offer some of its medicines “at the same prices available to other high-income nations.” The move will reduce prices by an average of 61% for certain medicines for diabetes, cardiovascular and neurological conditions and cancer, the company said. Some of the French pharma's offerings will also be available through TrumpRx.gov.GSK said it will make most of its inhaled respiratory disease therapies and other products available to patients on a direct purchasing platform, with savings of up to 66%.Novartis will also offer its multiple sclerosis drug Mayzent and cancer drugs Rydapt and Tabrecta through TrumpRx. Among them, Mayzent will come at a 89% discount from its list price, according to the White House fact sheet.Meanwhile, Genentech’s flu drug Xofluza and Boehringer’s diabetes med Jentadeuto will be accessible on TrumpRx at $50 and $55, respectively, representing discounts of 70% and 90%, respectively. Previously, for Lilly and Novo, MFN deals involved their popular diabetes and obesity drugs offered through DTC channels or through Medicaid and Medicare.For Pfizer, which was the first Big Pharma to reach a deal with the administration, the New York pharma is offering discounts for some of its drugs through TrumpRx.gov. Pfizer also agreed to offer certain drugs at MFN prices to Medicaid. While Trump in his letters to the 17 companies demanded the lowest available prices in the U.S., the actual determination of MFN benchmarks might not be as harsh as some may have feared.In November, the Centers for Medicare & Medicaid Services (CMS) unveiled a voluntary initiative called the GENEROUS model, which is designed to implement MFN pricing in participating state Medicaid programs for outpatient drugs. Under that model, the benchmark used to calculate the MFN prices is actually the “second lowest country-specific manufacturer-reported net price, adjusted by gross domestic product per capita using a purchasing power parity method,” according to the CMS.The country basket for price comparisons includes the U.K., France, Germany, Italy, Canada, Japan, Denmark and Switzerland, according to the agency.This model is scheduled to begin in January 2026 and will run for five years until the end of 2030.In its Dec. 19 release, Novartis said it will apply to participate in the GENEROUS model and will launch future medicines at prices comparable to those from other high-income countries. Besides the drug pricing components of the deals, drugmakers have also committed to increasing their investments in the U.S. to win over the White House. These investments are typically a combination of manufacturing expansions, R&D expenditures and business development activities. These funding pledges were made before MFN deals in response to Trump’s threat of tariffs on pharmaceuticals.

iStock, Sundry Photography The tickets could go to the lipid-lowering pill enlicitide decanoate and the antibody-drug conjugate sacituzumab tirumotecan, though a spokesperson for the HHS did not confirm the news. The FDA is considering giving Commissioner’s National Priority Vouchers to two investigational drugs from Merck, both with blockbuster potential, according to a Wednesday report from Reuters . After reviewing internal FDA documents, Reuters revealed that the cholesterol-lowering pill enlicitide decanoate and the antibody-drug conjugate (ADC) sacituzumab tirumotecan are each in the running for a priority voucher, which, if granted, would drastically reduce their respective review periods. Merck has yet to approval application for either of these molecules but the FDA expects a submission for enlicitide decanoate in April and sacituzumab tirumotecan in November of next year, according to Reuters . In a statement to Reuters , a spokesperson for the Department of Health and Human Services said that absent any official announcement from the FDA, reports regarding CNPV awards will remain speculative in nature. Enlicitide decanoate is an orally available blocker of the PCSK9 enzyme, working to reduce levels of low-density lipoprotein cholesterol (LDL-C). At the American Heart Association’s 2025 Scientific Sessions last month, the drug cut LDL-C concentrations by 55.8% versus placebo at 24 weeks. After Merck announced data showing enlicitide decanoate lowered cholesterol levels in two Phase III trials in June, BMO Capital Markets analysts wrote in a note to investors that the drug represented a “multi-billion dollar opportunity.” Meanwhile, Merck is developing sacituzumab tirumotecan for various oncology indications , including non-small cell lung cancer. Data from the Phase III OPtiTROP-Lung04 study, published in October in the New England Journal of Medicine , showed the ADC cut the risk of disease progression or death by 51% versus chemotherapy. Merck is also testing sacituzumab tirumotecan for breast, cervical, gastric, biliary tract, colorectal and pancreatic cancers. In November, Merck signed a $700 million funding agreement with Blackstone Life Sciences to develop the ADC. Jefferies analysts noted that the Blackstone deal indicated the molecule could reach $10 billion in sales, according to Reuters . The FDA rolled out the Commissioner’s National Priority Voucher program in June, looking to accelerate the approval process for drugs that satisfy certain federal priorities, such as lowering drug prices and boosting domestic manufacturing. These tickets shorten the regulatory review period from the usual 10–12 months to 1–2 months. Since the program’s launch, the FDA has handed out priority vouchers to 16 molecules, including Novo Nordisk’s weight-loss blockbuster Wegovy, Eli Lilly’s oral obesity candidate orforglipron and USAntibiotics’ antibiotic amoxicillin formulation Augmetin XR . Augmentin XR was approved earlier this month. Most recently, Johnson & Johnson earlier this week was granted a voucher—without even applying for it.