FDA nod for first triple combo pill for initial treatment of hypertension

George Medicines, a late-stage UK-based biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, revealed a regulatory approval that it says could reshape hypertension treatment in the USA.

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. The US commercial launch of WIDAPLIK is anticipated in fourth-quarter 2025 the company said.

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.