A new era of hypertension treatment is on the horizon for U.S. patients with the FDA approval of George Medicines’ Widaplik, a three-in-one pill that can serve as an initial treatment to help lower blood pressure.
The drug combines established high blood pressure meds telmisartan, amlodipine and indapamide and is the first triple-combination therapy to boast a label from the FDA that allows its use as an early treatment, helping patients who may need multiple drugs to achieve blood pressure goals with one fell swoop.
Its three dosing options—two low doses and one standard dose—can deliver the benefits of a triple-combo approach “early in the treatment pathway with an established safety profile and good tolerability,” according to a June 9 press release from George Medicines.
The drug is specifically approved for patients who are likely to need more than one medicine to achieve blood pressure goals.
In late-stage trials, George Medicines weighed Widaplik against placebo and dual combinations of telmisartan, amlodipine and indapamide. The studies found that the triple combo bested the other cohorts by improving patients' blood pressure and control rates.
The U.K.-based company is planning for a U.S. launch during the fourth quarter of this year, with additional regulatory submissions expected this year.
About 119 million adults in the U.S. have high blood pressure, according to the FDA. Even though more than half of U.S. adults have hypertension, only about 1 in 4 have their blood pressure under control, according to the agency. This "silent killer" puts patients at a higher risk for heart disease, heart failure and strokes, even if no symptoms are apparent, according to the FDA.
“Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control,” George Medicines’ CEO Mark Mallon said in a company press release. “Widaplik can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure.”
Widaplik will be sold with an FDA boxed warning urging patients to discontinue treatment “as soon as possible” after detecting pregnancy due to fetal toxicity.
George Medicines, an independent spin-out company from global health inequity research organization The George Institute for Global Health, isn’t stopping at hypertension. The company is investigating its combination treatment's potential in patients who have had intracerebral hemorrhage, a severe stroke where bleeding occurs within the brain tissue, an ongoing global trial.