FDA Approves GMRx2: First Triple-Combination Therapy for Initial Hypertension Treatment

George Medicines has received FDA approval for WIDAPLIK™ formerly known as GMRx2 (telmisartan/amlodipine/indapamide), the first and only triple-combination pill approved for initial treatment of hypertension and lower blood pressure in adults.
The FDA approval is based on positive results from two international Phase 3 trials – GMRx2_ACT and GMRx2_PCT – which compared WIDAPLIK against placebo and 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.

RemediumOne is honored to have supported this study as a clinical trial management organization in Sri Lanka, facilitating robust recruitment, regulatory coordination, and site operations. Sri Lanka recruited the highest number of participants (47%) out of 7 countries involved in the GMRx2_ACT study.

George Medicines announces FDA approval of WIDAPLIK™ (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment