George Medicines Receives FDA Approval For WIDAPLIK™ (Telmisartan, Amlodipine And Indapamide), A Once-Daily Triple Combination Pill For Hypertension In Adults

George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, has announced that the U.S. Food and Drug Administration (FDA) has approved WIDAPLIK (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults. This includes its use as an initial treatment to help lower blood pressure.

WIDAPLIK is a single-pill combination of three established medications: telmisartan, amlodipine, and indapamide. It is available in three dose options, a standard dose and two low-dose alternatives providing flexibility in treatment. It is the first and only FDA-approved triple-combination therapy approved for initial use in patients who are likely to need multiple medications to reach their blood pressure targets. The combination offers the benefits of three complementary mechanisms of action early in the treatment journey, along with a proven safety and tolerability profile.

Current global treatment guidelines increasingly support the use of single-pill combination therapies as the preferred approach for most patients with hypertension. In the United States, nearly half of all adults have high blood pressure, yet only about one in four have it under control. Hypertension remains a major contributor to cardiovascular disease, including heart attacks, stroke, and heart failure, and is linked to approximately 460,000 deaths annually in the country.

Mark Mallon, Chief Executive Officer of George Medicines, said in a statement, “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, mentioned, “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.”

FDA approval of WIDAPLIK is supported by results from two international Phase 3 clinical trials, which compared the medication to placebo and to dual combinations of its individual components. The trials demonstrated that WIDAPLIK led to significantly better blood pressure reductions and improved control rates. The most commonly reported side effect in these studies was symptomatic hypotension.

WIDAPLIK is contraindicated in patients with anuria, known hypersensitivity to any of its ingredients including sulfonamide-derived drugs and in individuals with diabetes taking aliskiren. The product carries a boxed warning advising discontinuation if pregnancy is detected, due to the risk of fetal toxicity. With this approval, George Medicines aims to offer a more effective and convenient option for treating hypertension, particularly for patients who would benefit from early and simplified combination therapy.