Amlodipine/Telmisartan/Indapamide

George Medicines plans to launch its Widaplik in the U.S. in the fourth quarter of this year. A new era of hypertension treatment is on the horizon for U.S. patients with the FDA approval of George Medicines’ Widaplik, a three-in-one pill that can serve as an initial treatment to help lower blood pressure.The drug combines established high blood pressure meds telmisartan, amlodipine and indapamide and is the first triple-combination therapy to boast a label from the FDA that allows its use as an early treatment, helping patients who may need multiple drugs to achieve blood pressure goals with one fell swoop. Its three dosing options—one low dose and two standard doses—can deliver the benefits of a triple-combo approach “early in the treatment pathway with an established safety profile and good tolerability,” according to a June 9 press release from George Medicines.The drug is specifically approved for patients who are likely to need more than one medicine to achieve blood pressure goals.In late-stage trials, George Medicines weighed Widaplik against placebo and dual combinations of telmisartan, amlodipine and indapamide. The studies found that the triple combo bested the other cohorts by improving patients' blood pressure and control rates.The U.K.-based company is planning for a U.S. launch during the fourth quarter of this year, with additional regulatory submissions expected this year. About 119 million adults in the U.S. have high blood pressure, according to the FDA. Even though more than half of U.S. adults have hypertension, only about 1 in 4 have their blood pressure under control, according to the agency. This "silent killer" puts patients at a higher risk for heart disease, heart failure and strokes, even if no symptoms are apparent, according to the FDA.“Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control,” George Medicines’ CEO Mark Mallon said in a company press release. “Widaplik can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure.”Widaplik will be sold with an FDA boxed warning urging patients to discontinue treatment “as soon as possible” after detecting pregnancy due to fetal toxicity.  George Medicines, an independent spin-out company from global health inequity research organization The George Institute for Global Health, isn’t stopping at hypertension. The company looks to save “tens of thousands of lives a year” with Widaplik for patients who have had intracerebral hemorrhage, a severe stroke where bleeding occurs within the brain tissue. An ongoing phase 3 trial program has so far shown that the treatment combo can significantly improve patients' chances of survival without suffering major disabilities.

Novel, single pill, triple combination with a standard dose and two lower doses that can deliver the efficacy benefits of combination therapy , with an established safety profile and good tolerability First and only triple combination for the initial treatment of hypertension Commercialization planning underway with US launch anticipated Q4 2025 London, UK, Boston, MA, 9 June 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, today announces that the US Food and Drug Administration (FDA) has approved WIDAPLIK™ (telmisartan, amlodipine and indapamide), formerly known as “GMRx2”, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. WIDAPLIK is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. WIDAPLIK, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability. Globally recognized treatment guidelines now recommend the use of single pill combination therapy for most patients and acknowledge the benefit of early use of combination therapy. In the US, nearly half of adults have hypertension and only around one in four have their blood pressure under control. Hypertension is a major risk factor for coronary heart disease, stroke and heart failure and is estimated to cause 460,000 deaths in the US each year. Mark Mallon, Chief Executive Officer of George Medicines, said: “Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control. WIDAPLIK can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure. With its triple combination efficacy, established safety profile, good tolerability and its availability in a single pill, WIDAPLIK has the potential to address key challenges in current hypertension treatment approaches. With planning underway for the upcoming US commercial launch of WIDAPLIK, and further regulatory submissions in other territories anticipated during 2025, George Medicines is well-positioned to positively impact the global burden of hypertension.” Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and Past President of the World Hypertension League, said: “I am very excited and pleased to have WIDAPLIK approved for the treatment of hypertension in the US. Single pill combination antihypertensive therapy has great potential to improve hypertension control in the US and worldwide. Most patients with hypertension need multiple therapies to achieve their blood pressure goals. The new dose options available with WIDAPLIK offer a treatment regimen that could benefit a broad range of patients, including those just starting treatment.” The FDA approval is based on positive results from two international Phase 3 trials, which compared WIDAPLIK against placebo and against dual combinations of its component drugs . In both trials WIDAPLIK significantly improved blood pressure and control rates vs comparators. In clinical trials, the most common adverse event reported in patients treated with WIDAPLIK is symptomatic hypotension. WIDAPLIK is contraindicated in patients with anuria, known hypersensitivity to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product. In patients with diabetes, WIDAPLIK is not to be co-administered with aliskiren. A boxed warning in the labeling informs physicians and patients to discontinue WIDAPLIK as soon as possible after pregnancy is detected due to fetal toxicity. For full Prescribing Information, visit here . The US commercial launch of WIDAPLIK is anticipated in Q4 2025. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company’s WIDAPLIK development program built on earlier research by The George Institute, including the 700-patient TRIUMPH trial undertaken in Sri Lanka in 2016/17, which found that among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill led to an increased proportion of patients achieving their target blood pressure goal versus usual care. George Medicines is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm. Ends About WIDAPLIK™ (GMRx2) WIDAPLIK is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, available in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg. WIDAPLIK is indicated for the treatment of hypertension, including as initial treatment, to lower blood pressure. Its development is backed by a comprehensive clinical program, including two pivotal Phase 3 studies, published in 2024 in the Journal of the American College of Cardiology and The Lancet . In these trials the triple combination demonstrated significantly reduced blood pressure (BP) and improved BP control rates, when compared against dual therapy and against placebo. In both trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. GMRx2 was investigated in the Nigerian VERONICA trial , which compared the triple combination with standard of care and reported better BP lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol. A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing. Please see full Prescribing Information including Boxed Warning for WIDAPLIK here . INDICATIONS WIDAPLIK TM is a prescription medicine used to treat high blood pressure (hypertension) in adults. WIDAPLIK may be used as the first medicine to lower your high blood pressure if your healthcare provider decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack. IMPORTANT SAFETY INFORMATION WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant. Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended. Do not take WIDAPLIK if you make less urine because of kidney problems (anuria). Do not take aliskiren-containing products with WIDAPLIK if you have diabetes. Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin. WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure. If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK. If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation. People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms. In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure, low blood sodium, or low blood potassium The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively. For further information, please see accompanying complete Prescribing Information for WIDAPLIK. To report SUSPECTED ADVERSE REACTIONS contact either: George Medicines at: safety@george-medicines.com or call 1-888-508-2083; or FDA at: www.fda.gov/medwatch or call 1-800-FDA-1088 About George Medicines George Medicines is a late-stage biopharmaceutical company addressing unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, each of which remain among the leading causes of premature death and disability worldwide. For more information, please visit www.george-medicines.com . Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to George Medicines’ financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential. In addition, this press release also contains forward looking statements relating to George Medicines’ growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including George Medicines’ ability to successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of drug candidates. Media contacts ICR Healthcare David Daley, Lindsey Neville, Tom Daniel georgemedicines@icrhealthcare.com ; Tel: +44 (0) 203 709 5700 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.