FDA Approves Widaplik Polypill for Hypertension Treatment

The U.S. Food and Drug Administration (FDA) has granted approval to George Medicines' new medication, Widaplik, designed to treat high blood pressure in adults. This innovative drug combines three antihypertensive agents—telmisartan, amlodipine, and indapamide—into a single pill, streamlining therapy for patients requiring multiple medications.

Widaplik stands out as the first and only FDA-approved triple combination pill intended as an initial treatment option for hypertension. It is available in a standard dose along with two lower-dose options, facilitating tailored treatment approaches and improving patient compliance.

The approval is grounded in positive outcomes from two comprehensive Phase III international trials. These studies compared Widaplik to dual-drug combinations and placebo, with results showing significant improvements in blood pressure control among patients who received Widaplik.

Common adverse effects reported include symptomatic low blood pressure, and Widaplik is contraindicated in individuals with kidney failure (anuria) or hypersensitivity to sulfonamide-derived drugs. It should not be used concomitantly with aliskiren in diabetic patients. Importantly, the medication carries a boxed warning to discontinue use during pregnancy.

According to Dr. Paul Whelton from Tulane University, the approval of Widaplik offers a promising step forward in hypertension management. He highlighted that single-pill therapies can greatly enhance blood pressure control globally, especially for patients needing multiple drugs to reach their targets. The availability of different dose options also broadens its suitability for diverse patient profiles.

More information about Widaplik and its approval process can be found at source.