Empagliflozin

The Maryland Prescription Drug Affordability Board (PDAB) found that Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) present affordability challenges for the residents of Maryland. Credit: Robert Kneschke/Shutterstock.com Maryland’s prescription drug affordability board (PDAB) passed resolutions affirming that Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) carry affordability challenges to the state’s residents, in a meeting on 28 July. These resolutions will now kickstart a process whereby the board will consider policy measures to address the affordability issues with these drugs, including one to set up an upper payment limit (UPL), which the pharma industry and several lobbying groups have consistently opposed. PDABs have been set up in at least 10 states in the US, with similar proposed legislation in several states. These state boards are made up of experts in the field, with most including physicians, health economists, pharmacists, and others. Each state has taken a unique approach with the framework governing these bodies with a distinct mandate and scope. However, the main objective across these boards is the same—to review and address rising prescription drug prices through several measures. Prescription drug prices have been in the news following tariffs, an executive order on the Most Favored Nation (MFN) policy , and the negotiations under the Inflation Reduction Act (IRA) for Medicare Part B drugs. Amidst these polices on the federal level, the role of states in influencing drug prices is often underestimated, but is still likely to be key given historical precedence, and recent Medicaid cuts . The Maryland PDAB made significant strides in formalising this review process, culminating in the July 28 meeting, where the board members deliberated on information contained in dossiers prepared for each drug. “The next step is we go into our policy review process,” Andrew York, Executive Director of the Maryland PDAB, tells Pharmaceutical Technology . Jardiance and Farxiga prices closely scrutinised After a drug is set to have an affordability challenge, the PDAB’s executive committee is tasked with finding the drivers behind those affordability challenges, and what policies the state can implement to address these, says York. Board meetings, like the latest Maryland PDAB, are usually livestreamed and are being closely followed by pharma companies, lobbyists, legal experts, patient advocacy organisations, and more. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence In the July 28 meeting, the board determined Farxiga had an ‘affordability challenge’ because the percentage change of its wholesale acquisition cost (WAC) over time was substantially higher than the rate of inflation; in certain cases, patient out-of-pocket costs were disproportionate to the net costs by the payers; and the total gross spending for Farxiga for state and local markets exceeded 1% of prescription drug spend for state and local governments. AstraZeneca did not respond to this news service for a comment, but in a July 5 letter to the board, an AstraZeneca spokesperson said that Farxiga accounts for only a fraction of the state’s spending—$20–30 million—while Maryland spends $6 billion on diabetes care. The spokesperson said the drug’s cost analysis does not take into account the burden of chronic kidney disease and heart failure, and the therapy’s impact in treating those conditions. In Jardiance’s case, the board said the drug presented an affordability challenge due to similar reasons, with the proportion of total gross spending for Jardiance by state and local governments exceeding 1.8% of gross spending for the state and local governments. Boehringer said the PDAB’s analysis using total gross spending did not represent out-of-pocket costs, or discounts and rebates that influence the final cost of a drug to a patient, in a July 9 letter. In 2024, Jardiance earned EUR8.4 billion ($8.8 billion), while Farxiga sales touched $7.7 billion. As part of the board proceedings being public, the cost review analysis made public includes information on each drug’s commercial and Medicaid utilization spending, its Medicare negotiated price, and more. Opinions divided on approach to improve access Chief among the concerns from pharma companies with PDABs is any measure to set a UPL on the drugs. On the subject of UPLs, York says, “That’s probably the thing that we’re most famous for. But right now, I think our board looks at it like it is a tool in the toolbox.” Throughout the public comment process, several patient advocates have expressed concerns that a UPL may deter companies from making their drugs available in a certain state. However, Peter Maybarduk, who directs the nonprofit Public Citizen’s access to medicines group, says this concern should not deter any review of drug prices. “Companies are responsible to shareholders. It [discontinuing access] would be extreme stance, especially if patients are outraged,” he says. Apart from Jardiance and Farxiga, both most commonly prescribed to patients with diabetes and cardiovascular issues, four other drugs have been chosen to be part of the drug review process—Novo Nordisk’s Ozempic (semaglutide), Eli Lilly’s Trulicity, AstraZeneca’s Dupixent (dupilumab), and AbbVie’s Skyrizi (risankizumab). York says the policy review for multiple drugs is likely to take place in parallel depending on whether they are said to present affordability challenges. The next meeting for the Maryland PDAB is scheduled for 15 September, 2025. This story is part of a reporting fellowship sponsored by the Association of Health Care Journalists and supported by The Commonwealth Fund. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. 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Group net sales grow by 6.3%* to EUR 14.0 billion, driven by Human Pharma (EUR 11.3 billion) and Animal Health (EUR 2.6 billion)Regulatory submissions underway for zongertinib and nerandomilast, with launches expected in H2 2025 Strategic investments in R&D and global manufacturing to drive innovation and support future growth Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported positive growth in the first half of 2025, with group net sales growing by 6.3%* to EUR 14.0 billion. This performance was driven by strong demand for key products in Human Pharma, namely JARDIANCE® with EUR 4.3 billion and OFEV® with EUR 2.0 billion, which continue to make a meaningful difference for patients worldwide. Building on this momentum, the company is advancing its late-stage pipeline with several therapies nearing regulatory approval. Among these are zongertinib for HER2-mutant lung cancer and nerandomilast for pulmonary fibrosis, both of which recently delivered positive pivotal results and are progressing towards potential launches in the second half of 2025. “At Boehringer Ingelheim, our commitment to transforming lives for generations is more than a mission — it's a responsibility we carry forward every day. Therapies like JARDIANCE® and OFEV® continue to make a real difference to patients — they exemplify what’s possible when true innovation addresses unmet medical needs,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma. “At the same time, we’re making strong progress across our pipeline — from obesity to liver and kidney health — with the goal of redefining standards of care. As we prepare for the potential launches of zongertinib and nerandomilast later this year, we remain focused on delivering meaningful solutions. We understand the urgency behind every patient’s need, and we’re acting with speed and purpose to meet it.” Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: “In a volatile environment, we are delivering according to plan, with robust sales performance across our portfolio in human and animal health. As we prepare for major launches, we are investing more than ever – focusing on speed, scale, and impact to ensure we are ready to deliver innovative therapies to change the course of serious diseases. Beyond the excitement of new launches, we also see substantial growth potential in our established products, particularly with JARDIANCE®, which continue to make a meaningful difference for patients worldwide.” Human Pharma In the first half of 2025, Boehringer Ingelheim’s Human Pharma business grew 5.7%* reaching EUR 11.3 billion in net sales. Growth was driven by solid global demand for key products, including EUR 4.3 billion in sales from JARDIANCE®, the treatment of chronic kidney diseases, type 2 diabetes and heart failure, and EUR 2.0 billion in sales from OFEV®, which is used to treat idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases. Boehringer Ingelheim’s human pharma pipeline is strong, with over ten new Phase II and III trials starting in the next 12 to 18 months across our multiple therapeutic areas. These could lead to major product launches over the next five years, offering the potential to transform millions of lives. U.S. launches for zongertinib and nerandomilast are expected in the second half of 2025, pending FDA approval. Zongertinib, a targeted therapy for HER2-mutant advanced non-small cell lung cancer (NSCLC), showed durable response and clinically meaningful results in previously treated patients, with more than 70% of patients experiencing a tumor response. It is under regulatory review in U.S., Japan and China and being studied as a first-line treatment in a global Phase III trial. If approved, it would become the first orally administered targeted treatment for previously treated HER2-mutated lung cancer patients. Nerandomilast, a potential therapy for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), significantly slowed lung-function decline in the two FIBRONEER™ Phase III trials. It was well tolerated, with discontinuation rates comparable to placebo. Regulatory submissions have been made in the U.S., EU, China and Japan. The company also launched a Phase III trial for our DPP1/CatC inhibitor verducatib (BI 1291583) to evaluate its potential in treating bronchiectasis. Verducatib received FDA breakthrough therapy designation in 2024. In cardiovascular, renal, and metabolic (CRM) diseases, Boehringer Ingelheim started two new Phase III trials under the ongoing EASi trial program. In these trials, the company is investigating the potential benefits of an aldosterone synthase inhibitor/SGLT2i therapy in people with chronic heart failure and for cardiovascular risk reduction in people with type 2 diabetes, high blood pressure and cardiovascular disease. To support future launches and continued growth, the company is continuing to strengthen its global supply network. A key milestone is the EUR 300 million investment in its Yamagata site in Japan, with the opening of a new production unit, infrastructure measures and groundbreaking for an additional facility began in June. This expansion will position Japan as a critical production hub for the Asia and Oceania regions. At the same time Boehringer continues to strengthen its local production network in the USA, building on existing partnerships. Animal Health In the first six months of 2025, Boehringer Ingelheim’s Animal Health Business delivered strong growth, with net sales increasing by 7.6%* to EUR 2.6 billion. This performance was driven by continued momentum in the parasiticide portfolio, particularly the NEXGARD® brand, which grew by 7.9%*. A key growth driver in Europe was BULTAVO 3™, a newly launched vaccine that protects cattle and sheep against bluetongue virus serotype 3 (BTV-3). BULTAVO 3™ is the first vaccine to prevent both clinical signs and mortality from BTV-3 and has been licensed in several European countries. The company also expanded its vaccine portfolio with the launch of VAXXITEK® HVT+IBD+H5, a trivalent poultry vaccine, offering protection against Marek’s disease, Infectious Bursal Disease, and H5 avian influenza in a single shot. It was first introduced in Egypt in early 2025 and is designed for administration directly at the hatchery, providing early protection for chicks. In the companion animal segment, Boehringer Ingelheim entered a strategic digital health collaboration with Eko Health to improve early detection of heart disease in dogs. The partnership combines Boehringer’s expertise in canine cardiology with Eko’s AI-powered stethoscope technology, aiming to launch a dedicated mobile app for veterinarians in 2026. Outlook As Boehringer Ingelheim enters the second half of 2025, the company is well-positioned to build on its first-half year performance and expects a positive year-on-year increase in net sales. With major product launches, a robust pipeline, and strategic investments in R&D and manufacturing, Boehringer Ingelheim is set to expand its global impact and bring innovative health solutions to more patients and animals worldwide. Visit our half-year financial highlights page HERE. * on a comparable basis (adjusted for currency and other effects) Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.   Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.