The U.S. FDA has approved George Medicines’ proprietary single pill combination, Widaplik, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure.
Widaplik is a combination of three medicines: telmisartan, amlodipine and indapamide. All three are older, off-patent drugs: telmisartan was first approved in 1998, as Boehringer Ingelheim’s Micardis; amlodipine was first approved in 1987, as Pfizer’s Norvasc; and indapamide was first marketed in 1983 as Lozol by Sanofi-Aventis.
George Medicines’ Widaplik, available in three doses, 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. According to the London-based company, it can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability.
The FDA approval is based on positive results from two international phase 3 trials, which compared Widaplik against placebo and against dual combinations of its component drugs.
The U.S. commercial launch of Widaplik is anticipated in Q4 2025.