FDA approves 3-in-1 polypill for hypertension
George Medicines, a London-based spin-out company of George Health, has received U.S. Food and Drug Administration (FDA) approval for a new polypill designed to treat hypertension in adult patients.
Widaplik is a combination tablet of telmisartan, amlodipine and indapamide. It will be available in three different doses when George Medicines officially launches the pill in Q4 2025. The FDA’s decision to approve Widaplik was based on data from two separate clinical trials that compared it safety and effectiveness to a placebo. The studies, published in the Journal of the American College of Cardiology and The Lancet in 2024, both link the medication with “clinically relevant” reductions in blood pressure.
“Widaplik can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure,” Mark Mallon, CEO of George Medicines, said in a statement. “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 U.S. 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.”
“I am very excited and pleased to have Widaplik approved for the treatment of hypertension in the U.S.,” added Paul Whelton, MD, MSc, chair of global public health at Tulane University and past president of the World Hypertension League. “Single pill combination antihypertensive therapy has great potential to improve hypertension control in the U.S. 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.”
Cardiologists see significant potential in polypills
Cardiologists have been praising the potential of polypills—single pills containing multiple pharmaceutical treatments—for many years now. Valentin Fuster, MD, PhD, president of Mount Sinai Fuster Heart Hospital, physician-in-chief of The Mount Sinai Hospital—and one of cardiology’s most influential voices—spent years leading research on the benefits of polypills. He was one of the many voices cheering the World Health Organization’s 2023 endorsement of polypills for the treatment of cardiovascular disease.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.